Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03357133
Status:
TERMINATED
Last Update Posted:
2020-09-09
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tirofiban for Patients Treated With Alteplase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077466', 'term': 'Tirofiban'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'The number and speed of enrollment were significantly less than expected.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-06', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-11-23', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': '7 days or discharge'}, {'measure': 'Severe systemic bleeding', 'timeFrame': '7 days or discharge'}, {'measure': 'Stroke-related death', 'timeFrame': '90 days'}, {'measure': 'Death form any cause', 'timeFrame': '90 days'}], 'primaryOutcomes': [{'measure': 'The rate of favorable outcome', 'timeFrame': '90 days', 'description': 'favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale'}], 'secondaryOutcomes': [{'measure': 'mRS ≤2', 'timeFrame': '90 days'}, {'measure': 'NIHSS score', 'timeFrame': '7 days'}, {'measure': 'Deterioration after improvement', 'timeFrame': '24 hours'}, {'measure': 'Final infarct size', 'timeFrame': '24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.\n* 6≤ NIHSS ≤20 before IV tPA, or NIHSS \\>20 but decrease ≥ 8 after IV rt-PA.\n* ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage\n* Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form\n\nExclusion Criteria:\n\n* Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.\n* Patients had used antiplatelet therapy in the past 5 days before the stroke.\n* Patients had used anticoagulant therapy in the past 5 days before the stroke.\n* Scheduled for surgery or interventional treatment requiring study drug cessation.\n* CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.\n* Any evidence of clinically significant bleeding ,or known coagulopathy.\n* Renal insufficiency (creatinine clearance rate \\<30ml/min)\n* Hepatic dysfunction (ALT \\>2 folds of Upper limit of normal value or AST\\>2 folds of Upper limit of normal value).\n* Pre-existing disability with ≥ mRS 2.\n* Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.\n* Severe non-cerebrovascular disease with life expectancy \\<3 months'}, 'identificationModule': {'nctId': 'NCT03357133', 'acronym': 'MR TEA', 'briefTitle': 'Tirofiban for Patients Treated With Alteplase', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis', 'orgStudyIdInfo': {'id': '2017032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirofiban and alteplase', 'interventionNames': ['Drug: Tirofiban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Alteplase', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Tirofiban', 'type': 'DRUG', 'description': 'Tirofiban Injection after the alteplase intravenous thrombolysis', 'armGroupLabels': ['Tirofiban and alteplase']}, {'name': 'Alteplase', 'type': 'DRUG', 'description': 'Only alteplase intravenous thrombolysis', 'armGroupLabels': ['Alteplase']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Anhui', 'country': 'China', 'facility': 'Suzhou Municipal Hoapital', 'geoPoint': {'lat': 33.63611, 'lon': 116.97889}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Luohe', 'state': 'Henan', 'country': 'China', 'facility': 'The Central Hospital of Luohe City', 'geoPoint': {'lat': 33.56394, 'lon': 114.04272}}, {'city': 'Luzhou', 'state': 'Sichuan', 'country': 'China', 'facility': "Luzhou People's Hospital", 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'city': 'Xiangtan', 'country': 'China', 'facility': 'Xiangtan Central Hospital', 'geoPoint': {'lat': 27.85, 'lon': 112.9}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'The Fifth Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}