Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-05 @ 9:55 PM
Study NCT ID:
NCT00546260
Status:
TERMINATED
Last Update Posted:
2023-08-16
First Post:
2007-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kromanko@portola.com', 'phone': '650-246-7305', 'title': 'Kevin Romanko, Senior Director Clinical Operations', 'organization': 'Portola Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. Additionally, individual publication may occur after coordinated multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Because Part II of the study was not completed and Part I had a small sample size, no conclusions could be drawn regarding efficacy.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo Comparator', 'otherNumAtRisk': 36, 'otherNumAffected': 15, 'seriousNumAtRisk': 36, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Experimental', 'description': 'Experimental Cohorts (10, 20, 40, 60 mg)', 'otherNumAtRisk': 34, 'otherNumAffected': 21, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Peripheral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental Cohorts (10, 20, 40, 60 mg)'}], 'classes': [{'title': 'Dose 10 mg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dose 20 mg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dose 40 mg', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Dose 60 mg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.\n\nTIMI Minor:Hemoglobin concentration decreased by 3g/dL (but \\<5g/dL) or the hematocrit decreased by 10-15%.\n\nGUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.\n\nGUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.\n\nStroke:New focal neurologic deficit that does not resolve within 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects receiving some component of study drug (the "as-treated" population)'}, {'type': 'SECONDARY', 'title': 'Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental Cohorts (10, 20, 40, 60 mg)'}], 'classes': [{'title': 'Dose 10 mg', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '100'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '100'}]}]}, {'title': 'Dose 20 mg', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Dose 40 mg', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Dose 60 mg', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time for contrast to reach a standardized distal coronary landmark in the culprit vessel', 'description': 'This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.', 'unitOfMeasure': 'frames per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Percentage ST-segment Resolution Prior to PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental Cohorts (10, 20, 40, 60 mg)'}], 'classes': [{'title': 'Dose 10 mg', 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '100'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '100'}]}]}, {'title': 'Dose 20 mg', 'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '83'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '63.2', 'upperLimit': '100'}]}]}, {'title': 'Dose 40 mg', 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '62.8', 'upperLimit': '100'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '66.3'}]}]}, {'title': 'Dose 60 mg', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '100'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '92.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Before primary PCI', 'description': 'The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.', 'unitOfMeasure': 'Percentage of ST-segment Resolution', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'Experimental Cohorts (10, 20, 40, 60 mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Drug not given pre diagnostic angiogr', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'Experimental Cohorts (10, 20, 40, 60 mg)'}, {'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': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'Administrative reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2007-10-16', 'resultsFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2007-10-17', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-28', 'studyFirstPostDateStruct': {'date': '2007-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days', 'timeFrame': '30 days', 'description': 'TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.\n\nTIMI Minor:Hemoglobin concentration decreased by 3g/dL (but \\<5g/dL) or the hematocrit decreased by 10-15%.\n\nGUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.\n\nGUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.\n\nStroke:New focal neurologic deficit that does not resolve within 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI', 'timeFrame': 'Time for contrast to reach a standardized distal coronary landmark in the culprit vessel', 'description': 'This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.'}, {'measure': 'Percentage ST-segment Resolution Prior to PCI', 'timeFrame': 'Before primary PCI', 'description': 'The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['STEMI', 'ACS'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '19958867', 'type': 'DERIVED', 'citation': 'Berger JS, Roe MT, Gibson CM, Kilaru R, Green CL, Melton L, Blankenship JD, Metzger DC, Granger CB, Gretler DD, Grines CL, Huber K, Zeymer U, Buszman P, Harrington RA, Armstrong PW. Safety and feasibility of adjunctive antiplatelet therapy with intravenous elinogrel, a direct-acting and reversible P2Y12 ADP-receptor antagonist, before primary percutaneous intervention in patients with ST-elevation myocardial infarction: the Early Rapid ReversAl of platelet thromboSis with intravenous Elinogrel before PCI to optimize reperfusion in acute Myocardial Infarction (ERASE MI) pilot trial. Am Heart J. 2009 Dec;158(6):998-1004.e1. doi: 10.1016/j.ahj.2009.10.010.'}], 'seeAlsoLinks': [{'url': 'http://www.portola.com', 'label': 'Sponsor home page'}]}, 'descriptionModule': {'briefSummary': 'Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)', 'detailedDescription': 'Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥ 0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset within 6 hours of hospital presentation.\n\nExclusion Criteria:\n\n* Cardiogenic shock (systolic blood pressure \\< 90 mm Hg requiring vasopressor or hemodynamic support)\n* Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) \\> 180 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.\n* Recent gastrointestinal bleeding within the last 30 days.\n* Known thrombocytopenia (platelet count \\< 100,000/mm3).\n* Any treatment with a fibrinolytic agent within the last 7 days.'}, 'identificationModule': {'nctId': 'NCT00546260', 'acronym': 'ERASE-MI', 'briefTitle': 'Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'Randomized Trial to Evaluate Effect of Adjunctive Antiplatelet Therapy With Intravenous PRT060128, a Selective P2Y12-Receptor Inhibitor, Before Primary Percutaneous Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) Patients', 'orgStudyIdInfo': {'id': '07-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo for each Dose cohort: 10, 20, 40, and 60 mg', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg', 'interventionNames': ['Drug: PRT060128 Potassium']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'administration of iv bolus prior to angiography', 'armGroupLabels': ['1']}, {'name': 'PRT060128 Potassium', 'type': 'DRUG', 'description': 'administration of iv bolus prior to angiography', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Memorial Medical Center', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Hospital, Gill Heart Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '20912', 'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Washington Adventist Hospital', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '48341', 'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy - Oakland', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital - Troy Cardiology', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lindner Clinical Trial Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Heart Center', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': 'T2N2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5H3V7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandria Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Heart Institute, Royal Jubilee Hospital', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'E2L4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Atlantic Health Services', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'General Hospital - Heath Sciences Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5B2P7', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Trillium Health Centre - Mississaugua', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y2R2', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Soutlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M4N3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Montreal - Hotel Dieu', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4N1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hospital du Sacre Coeur', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S4P0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Regina General Hospital', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}], 'overallOfficials': [{'name': 'Matthew T. Roe, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}, {'name': 'Michael Gibson, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PERFUSE Angiographic Core Laboratory and Data Coordinating Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portola Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Daniel Gretler, MD', 'oldOrganization': 'Portola Pharmaceuticals, Inc.'}}}}