Viewing Study NCT00894803

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 7:16 PM
Ignite Modification Date: 2025-12-28 @ 12:18 PM
Study NCT ID: NCT00894803
Status: COMPLETED
Last Update Posted: 2014-04-17
First Post: 2009-05-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077542', 'term': 'Eptifibatide'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arthur.pancioli@uc.edu', 'phone': '513-558-8087', 'title': 'Dr Arthur Pancioli', 'organization': 'University of Cincinnati'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 90 days from initiation of therapy', 'description': 'Adverse events were documented as recorded in the medical record until discharge. The occurrence of adverse events from the time of hospital discharge to the 90 day visit was collected at the time of the 90 day visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)', 'otherNumAtRisk': 25, 'otherNumAffected': 17, 'seriousNumAtRisk': 25, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)', 'otherNumAtRisk': 101, 'otherNumAffected': 80, 'seriousNumAtRisk': 101, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Administration site reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Administration site reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Allergic conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Anaemias nonhaemolytic and marrow depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Angioedema and urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Anxiety disorders and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Arteriosclerosis, stenosis, vascular insufficiency and necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Bacterial infectious disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Body temperature conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Bone, calcium, magnesium and phosphorus metabolism disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Bronchial disorders (excl neoplasms)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Cardiac arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Cardiac disorder signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Central nervous system vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Changes in physical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Cognitive and attention disorders and disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Coronary artery disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Decreased and nonspecific blood pressure disorders and shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Dental and gingival conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Depressed mood disorders and disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Device issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Electrolyte and fluid balance conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Embolism and thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Enzyme investigations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Epidermal and dermal conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Eye disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Fungal infectious disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Gastrointestinal motility and defaecation conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Gastrointestinal signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'General system disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Genitourinary tract disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Glucose metabolism disorders (incl diabetes mellitus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Glucose metabolism disorders (incl diabetes mellitus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Haematology investigations (incl blood groups)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Heart failures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Increased intracranial pressure and hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Infections - pathogen unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Joint disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Lower respiratory tract disorders (excl obstruction and infection)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Muscle disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Musculoskeletal and connective tissue disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Neurological disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Neuromuscular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Penile and scrotal disorders (excl infections and inflammations)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Physical examination and organ system status topics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Pleural disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Procedural related injuries and complications NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Renal disorders (excl nephropathies)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Respiratory disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Seizures (incl subtypes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Sleep disorders and disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Sleep disturbances (incl subtypes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Tongue conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Upper respiratory tract disorders (excl infections)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Urinary tract signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Urolithiases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Vascular haemorrhagic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Water, electrolyte and mineral investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'White blood cell disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}], 'seriousEvents': [{'term': 'Anaemias nonhaemolytic and marrow depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Arteriosclerosis, stenosis, vascular insufficiency and necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Cardiac therapeutic procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Central nervous system vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Communication disorders and disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Coronary artery disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Deliria (incl confusion)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Embolism and thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Gallbladder disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Gastrointestinal haemorrhages NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Gastrointestinal inflammatory conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Gastrointestinal signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'General system disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Genitourinary tract disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Heart failures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Increased intracranial pressure and hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Infections - pathogen unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Muscle disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Neurological disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Neuromuscular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Pulmonary vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Renal disorders (excl nephropathies)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Respiratory disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Seizures (incl subtypes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Vascular haemorrhagic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}, {'term': 'Vascular therapeutic procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA, version 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'sICH within 36 hours of treatment onset', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No sICH within 36 hours of treatment onset', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.01', 'ciUpperLimit': '1.40', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'an exact logistic regression was used due to the number of events', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 36 hours of initiation of therapy', 'description': 'Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'mRS of 0-1 or return to baseline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'mRS >1 and > baseline', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '0.70', 'ciUpperLimit': '4.31', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.51', 'ciUpperLimit': '3.71', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for age, baseline NIHSS score and time to IV rt-PA', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days from treatment onset', 'description': 'Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of \'6\', and assigned the "bad" outcome. Also those lost to follow-up were assigned the "bad" outcome.\n\nThe Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serious Systemic Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'Serious systemic bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No Serious systemic bleeding', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Incidence of serious systemic bleeding defined as requiring transfusion of 2 or more units of packed red blood cells.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'sICH within 7 days of treatment onset', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No sICH within 7 days of treatment onset', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.01', 'ciUpperLimit': '1.40', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Exact method used due to number of responses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'asICH within 7 days of treatment onset', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'No asICH within 7 days of treatment onset', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.35', 'ciUpperLimit': '8.02', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Any ICH observed on CT by the study site neuroradiologist and the independent study neuroradiologist; the central reader. The ICH would not be related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH,where judgment of significant neurological decline was made by the local clinical investigator. A third independent reader will make the final determination if there is disagreement between the treating investigator and the central reader', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Death Within 7 Days of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'Death within 7 days of treatment onset', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No death within 7 days of treatment onset', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.24', 'ciUpperLimit': '5.92', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Exact method used due to small number of responses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Death due to any cause within 7 days of treatment onset', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Death Due to Stroke Within 7 Days of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'Death due to stroke within 7 days of treatment ons', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No Death due to stroke within 7 days of treatment', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.24', 'ciUpperLimit': '5.92', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Exact method used due to number of responses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Death due to stroke within 7 days of treatment onset. Classified by blinded clinical investigators', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Death Within 90 Days of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'Death within 90 days of treatment onset', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'No death within 90 days of treatment onset', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.38', 'ciUpperLimit': '5.76', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Exact methods used due t number of responses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 90 days of treatment onset', 'description': 'Death due to any cause within 90 days of treatment onset', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Death Due to Stroke Within 90 Days of Treatment Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'Death due to stroke within 90 days of treatment on', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'No Death due to stroke within 90 days of treatment', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.92', 'ciLowerLimit': '0.26', 'ciUpperLimit': '4.18', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Exact method used due to number of responses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 90 days of treatment onset', 'description': 'Death due to stroke within 90 days of treatment onset. Classified by blinded clinical investigators', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Barthel Index ≥ 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'Barthel Index ≥ 95', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Barthel Index < 95', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.63', 'ciUpperLimit': '3.67', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.40', 'ciUpperLimit': '3.02', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for age, baseline NIHSS and time to IV rt-PA', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days from treatment onset', 'description': 'Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the "bad" outcome.\n\nThe Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glasgow Outcome Scale (GOS) of 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'GOS =1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'GOS > 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.65', 'ciUpperLimit': '3.88', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.44', 'ciUpperLimit': '3.24', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for age, baseline NIHSS and time to IV rt-PA', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days from treatment onset', 'description': 'Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the "bad" outcome.\n\nThe Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NIH Stroke Scale Score (NIHSS) ≤ 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'NIHSS ≤ 5', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'NIHSS > 5', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '0.61', 'ciUpperLimit': '4.99', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 2 hours of treatment onset', 'description': 'Study subjects with an NIH stroke scale score of ≤ 5 at 2 hours from treatment onset, those sedated and unable to be evaluated by the NIHSS were assigned the "bad" outcome (n=1).\n\nThe NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NIH Stroke Scale Score (NIHSS) ≤ 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'NIHSS ≤ 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'NIHSS > 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '0.47', 'ciUpperLimit': '4.07', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours of treatment onset', 'description': 'Study subjects with an NIH stroke scale score of ≤ 2 at 24 hours from treatment onset, those dead (n=1) or sedated and unable to be evaluated by the NIHSS were assigned the "bad" outcome (n=5).\n\nThe NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'NIHSS ≤ 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'NIHSS > 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.46', 'ciUpperLimit': '2.67', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days from treatment onset', 'description': 'Study subjects with an NIH stroke scale score ≤ 2 points at 90 days from treatment onset compared to baseline value, those dead or unable to be evaluated by the NIHSS were assigned the "bad" outcome.\n\nThe NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Modified Rankin Scale (mRS) of 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'OG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}], 'classes': [{'title': 'mRS of 0-1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'mRS > 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '0.90', 'ciUpperLimit': '6.64', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '0.67', 'ciUpperLimit': '5.88', 'estimateComment': 'Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for age, baseline NIHSS and time to IV rt-PA', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days from treatment onset', 'description': 'Modified Rankin Scale of 0 or 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of \'6\', and assigned the "bad" outcome. Also those lost to follow-up were assigned the "bad" outcome.\n\nThe Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rt-PA and Eptifibatide', 'description': 'recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)'}, {'id': 'FG001', 'title': 'Rt-PA Only', 'description': 'recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted in emergency departments at 9 US medical centers comprised of 21 hospitals. Subjects were recruited between July 2009 and October 2012.', 'preAssignmentDetails': 'No enrolled participants were excluded from the trial before assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rt-PA Only', 'description': 'rt-PA (0.9 mg/kg)'}, {'id': 'BG001', 'title': 'Rt-PA and Eptifibatide', 'description': 'rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'groupId': 'BG000', 'lowerLimit': '60.5', 'upperLimit': '81.4'}, {'value': '71.6', 'groupId': 'BG001', 'lowerLimit': '58.1', 'upperLimit': '81.5'}, {'value': '74.2', 'groupId': 'BG002', 'lowerLimit': '58.1', 'upperLimit': '81.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'National Institutes of Health Stroke Scale Score (NIHSS)', 'classes': [{'title': 'NIHSS <=12', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'NIHSS >12', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'National Institutes of Health Stroke Scale Score (NIHSS), 43 point ordinal scale (0 to 42), measuring severity of stroke. 0 (no measurable effect), 42 (dead).', 'unitOfMeasure': 'Participants'}, {'title': 'National Institutes of Health Stroke Scale Score (NIHSS)', 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '14.1', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'National Institutes of Health Stroke Scale Score (NIHSS), 43 point ordinal scale (0 to 42), measuring severity of stroke. 0 (no measurable effect), 42 (dead).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'National Institutes of Health Stroke Scale Score (NIHSS)', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '22'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'description': 'National Institutes of Health Stroke Scale Score (NIHSS), 43 point ordinal scale (0 to 42), measuring severity of stroke. 0 (no measurable effect), 42 (dead).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Stroke symptom onset to intravenous rt-PA start', 'classes': [{'title': '< 1 hour', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '1 to 2 hours', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': '>2 to 3 hours', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': '> 3 hours', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Time from stroke symptom onset to intravenous rt-PA start', 'unitOfMeasure': 'Participants'}, {'title': 'Stroke symptom onset to intravenous rt-PA start', 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000', 'lowerLimit': '90', 'upperLimit': '141'}, {'value': '113', 'groupId': 'BG001', 'lowerLimit': '99', 'upperLimit': '135'}, {'value': '116', 'groupId': 'BG002', 'lowerLimit': '97', 'upperLimit': '138'}]}]}], 'paramType': 'MEDIAN', 'description': 'Tme from stroke symptom onset to intravenous rt-PA start', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Modified Rankin Score (mRS)', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'modified Rankin Score (mRS), 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-26', 'studyFirstSubmitDate': '2009-05-06', 'resultsFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2009-05-06', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-28', 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious Systemic Bleeding', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Incidence of serious systemic bleeding defined as requiring transfusion of 2 or more units of packed red blood cells.'}, {'measure': 'Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator'}, {'measure': 'Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Any ICH observed on CT by the study site neuroradiologist and the independent study neuroradiologist; the central reader. The ICH would not be related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH,where judgment of significant neurological decline was made by the local clinical investigator. A third independent reader will make the final determination if there is disagreement between the treating investigator and the central reader'}, {'measure': 'Death Within 7 Days of Treatment Onset', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Death due to any cause within 7 days of treatment onset'}, {'measure': 'Death Due to Stroke Within 7 Days of Treatment Onset', 'timeFrame': 'Within 7 days of treatment onset', 'description': 'Death due to stroke within 7 days of treatment onset. Classified by blinded clinical investigators'}, {'measure': 'NIH Stroke Scale Score (NIHSS) ≤ 5', 'timeFrame': 'Within 2 hours of treatment onset', 'description': 'Study subjects with an NIH stroke scale score of ≤ 5 at 2 hours from treatment onset, those sedated and unable to be evaluated by the NIHSS were assigned the "bad" outcome (n=1).\n\nThe NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death.'}, {'measure': 'NIH Stroke Scale Score (NIHSS) ≤ 2', 'timeFrame': 'Within 24 hours of treatment onset', 'description': 'Study subjects with an NIH stroke scale score of ≤ 2 at 24 hours from treatment onset, those dead (n=1) or sedated and unable to be evaluated by the NIHSS were assigned the "bad" outcome (n=5).\n\nThe NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death.'}, {'measure': 'NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days', 'timeFrame': '90 days from treatment onset', 'description': 'Study subjects with an NIH stroke scale score ≤ 2 points at 90 days from treatment onset compared to baseline value, those dead or unable to be evaluated by the NIHSS were assigned the "bad" outcome.\n\nThe NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death.'}], 'primaryOutcomes': [{'measure': 'Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset', 'timeFrame': 'Within 36 hours of initiation of therapy', 'description': 'Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator'}, {'measure': 'Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline', 'timeFrame': '90 days from treatment onset', 'description': 'Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of \'6\', and assigned the "bad" outcome. Also those lost to follow-up were assigned the "bad" outcome.\n\nThe Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care).'}], 'secondaryOutcomes': [{'measure': 'Barthel Index ≥ 95', 'timeFrame': '90 days from treatment onset', 'description': 'Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the "bad" outcome.\n\nThe Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent.'}, {'measure': 'Glasgow Outcome Scale (GOS) of 1', 'timeFrame': '90 days from treatment onset', 'description': 'Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the "bad" outcome.\n\nThe Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'stroke', 'rt-PA, thrombolytic', 't-PA', 'recombinant tissue plasminogen activator', 'Activase', 'eptifibatide', 'Integrilin', 'fibrinolytic agents', 'clot dissolving', 'blood clot'], 'conditions': ['Ischemic Stroke', 'Stroke', 'Brain Infarction']}, 'referencesModule': {'references': [{'pmid': '23887845', 'type': 'BACKGROUND', 'citation': 'Barreto AD, Pedroza C, Grotta JC. Adjunctive medical therapies for acute stroke thrombolysis: is there a CLEAR-ER choice? Stroke. 2013 Sep;44(9):2377-9. doi: 10.1161/STROKEAHA.113.001830. Epub 2013 Jul 25. No abstract available.'}, {'pmid': '23887841', 'type': 'RESULT', 'citation': 'Pancioli AM, Adeoye O, Schmit PA, Khoury J, Levine SR, Tomsick TA, Sucharew H, Brooks CE, Crocco TJ, Gutmann L, Hemmen TM, Kasner SE, Kleindorfer D, Knight WA, Martini S, McKinney JS, Meurer WJ, Meyer BC, Schneider A, Scott PA, Starkman S, Warach S, Broderick JP; CLEAR-ER Investigators. Combined approach to lysis utilizing eptifibatide and recombinant tissue plasminogen activator in acute ischemic stroke-enhanced regimen stroke trial. Stroke. 2013 Sep;44(9):2381-7. doi: 10.1161/STROKEAHA.113.001059. Epub 2013 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.', 'detailedDescription': "The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA (recombinant tissue plasminogen activator) in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER Stroke) trial is a Phase II trial and part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers.\n\nStroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible.\n\nrt-PA, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Eptifibatide is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of eptifibatide for a stroke victim in combination with rt-PA.\n\nThe CLEAR Stroke Trial (NCT00250991) demonstrated that the combination of low dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.\n\nThe CLEAR-ER Stroke Trial is designed to provide data concerning the risks and benefits of combining eptifibatide with medium dose intravenous rt-PA in 126 acute ischemic stroke patients within 3 hours of symptom onset. Patients will be randomized to a combined intravenous medium-dose rt-PA and eptifibatide regimen, or standard dose rt-PA in a 5 to 1 ratio. This will result in a total of 105 patients treated with a combined regimen, and 21 patients treated with standard dose IV rt-PA alone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a serious measurable neurological deficit on the NIH Stroke Scale due to focal brain ischemia.\n* An NIH Stroke Scale score \\>5 at the time the rt-PA is begun.\n* Age: 18 through 85 years (i.e. candidates must have had their 18th birthday, but not had their 86th birthday).\n* Intravenous rt-PA therapy must be initiated within 3 hours of onset of stroke symptoms.\n\nExclusion Criteria:\n\n* History of stroke in the past 3 months.\n* Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.\n* Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal.\n* Hypertension at time of treatment; systolic BP \\> 185 or diastolic \\> 110 mmHg or aggressive measures to lower blood pressure to below these limits are needed.\n* Presumed septic embolus.\n* Presumed pericarditis including pericarditis after acute myocardial infarction.\n* Recent (within 30 days) surgery or biopsy of parenchymal organ.\n* Recent (within 30 days) trauma, with internal injuries or ulcerative wounds.\n* Recent (within 90 days) severe head trauma or head trauma with loss of consciousness.\n* Any active or recent (within 30 days) serious systemic hemorrhage.\n* Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with Iinternational Normalized Ratio (INR) \\> 1.7.\n* Baseline lab values: positive urine pregnancy test, glucose \\< 50 or \\> 400 mg/dl, platelets \\<100,000 /mm3, Hct (hematocrit) \\<25 %, or creatinine \\> 4 mg/dl.\n* Ongoing renal dialysis, regardless of creatinine.\n* If heparin has been administered within 48 hours, the patient must have a normal partial thromboplastin time (PTT).\n* Arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days.\n* Seizure at onset of stroke.\n* Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.\n* Other serious, advanced, or terminal illness or any other condition that the investigator feels would pose a significant hazard to the patient if rt-PA or eptifibatide therapy were initiated.\n* Patients whose peripheral venous access is so poor that they are unable to have two standard peripheral intravenous lines started.\n* Current participation in another research drug treatment protocol. Patient cannot start another experimental agent until after 90 days.\n* Informed consent is not or cannot be obtained.\n* Any known history of amyloid angiopathy.\n* High density lesion consistent with hemorrhage of any degree.\n* Significant mass effect with midline shift.\n* Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment.'}, 'identificationModule': {'nctId': 'NCT00894803', 'acronym': 'CLEAR-ER', 'briefTitle': 'Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'The "Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Enhanced Regimen" (CLEAR-ER Stroke Trial)', 'orgStudyIdInfo': {'id': 'P50NS04483-06'}, 'secondaryIdInfos': [{'id': '00894803', 'type': 'REGISTRY', 'domain': 'NCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rt-PA only', 'description': 'Subject will receive the standard dose (0.9mg/kg) of IV rt-PA given over 60 minutes. One out of 6 subjects will be in this group.', 'interventionNames': ['Drug: rt-PA']}, {'type': 'EXPERIMENTAL', 'label': 'rt-PA and Eptifibatide', 'description': 'Subject will receive the standard dose (0.9mg/kg) of IV rt-PA. This IV dose will be discontinued at 40 minutes. The subject will immediately receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Five out of six subjects will be in this group.', 'interventionNames': ['Drug: Eptifibatide', 'Drug: rt-PA']}], 'interventions': [{'name': 'Eptifibatide', 'type': 'DRUG', 'otherNames': ['Integrilin'], 'description': 'IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.', 'armGroupLabels': ['rt-PA and Eptifibatide']}, {'name': 'rt-PA', 'type': 'DRUG', 'otherNames': ['Activase'], 'description': 'Intravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy.', 'armGroupLabels': ['rt-PA and Eptifibatide', 'rt-PA only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Ronald Reagan Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center Santa Monica', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Healthcare Edgewood', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '41042', 'city': 'Florence', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Healthcare Florence', 'geoPoint': {'lat': 38.99895, 'lon': -84.62661}}, {'zip': '41075', 'city': 'Fort Thomas', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Healthcare Ft. Thomas', 'geoPoint': {'lat': 39.07506, 'lon': -84.44716}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Suburban Hospital', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital, Inc.', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45220-2489', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Jewish Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45238', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Hospital, Western Hills', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45239', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Hospital Mt Airy', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Hospital', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Arthur M Pancioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati College of Medicine Department of Emergency Medicine'}, {'name': 'Opeolu M Adeoye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati College of Medicine Department of Emergency Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dir Academic Med', 'investigatorFullName': 'Arthur Pancioli', 'investigatorAffiliation': 'University of Cincinnati'}}}}