Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-13 @ 2:03 PM
Study NCT ID:
NCT02545933
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2015-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'C530299', 'term': 'vorapaxar'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dominick.angiolillo@jax.ufl.edu', 'phone': '9042443378', 'title': 'Dr. Dominick Angiolillo', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study (30 days)', 'eventGroups': [{'id': 'EG000', 'title': 'DAPT Plus Vorapaxar', 'description': 'Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 9, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prasugrel/Ticagrelor Plus Vorapaxar', 'description': 'Prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 6, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DAPT', 'description': 'Aspirin in addition to prasugrel or ticagrelor\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 4, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'BARC 1 bleeding', 'notes': 'BARC (Bleeding Academic Research Consortium) 1 bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Platelet Aggregation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DAPT Plus Vorapaxar', 'description': 'Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'OG001', 'title': 'Prasugrel/Ticagrelor Plus Vorapaxar', 'description': 'Prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'OG002', 'title': 'DAPT', 'description': 'Aspirin in addition to prasugrel or ticagrelor\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '21', 'groupId': 'OG000'}, {'value': '64', 'spread': '20', 'groupId': 'OG001'}, {'value': '74', 'spread': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27', 'ciLowerLimit': '19', 'ciUpperLimit': '34', 'estimateComment': 'DAPT group vs DAPT plus vorapaxar group', 'groupDescription': 'We hypothesized that adjunctive vorapaxar would result in a significant reduction of CAT-induced platelet aggregation. Assuming a 10% absolute reduction in CAT-induced maximal platelet aggregation with a common standard deviation of 13%, 37 patients per group with valid primary endpoint data were required to detect a significant difference with a 90% power and 2-sided alpha=0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The primary end point of our study is the comparison of maximal platelet aggregation measured by light transmittance aggregometry using CAT (collagen-ADP-TRAP) between DAPT and DAPT plus vorapaxar after 30 days of treatment.', 'unitOfMeasure': 'percent aggregation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '130 patients were randomized and exposed to at least one dose of study medication (triple therapy, n=44; dual therapy, n= 43; DAPT, n=43). Of these, 115 patients (triple therapy, n=37; dual therapy, n= 39; DAPT, n=39) had valid primary endpoint data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DAPT Plus Vorapaxar', 'description': 'Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'FG001', 'title': 'Prasugrel/Ticagrelor Plus Vorapaxar', 'description': 'Prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'FG002', 'title': 'DAPT', 'description': 'Aspirin in addition to prasugrel or ticagrelor\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DAPT Plus Vorapaxar', 'description': 'Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'BG001', 'title': 'Prasugrel/Ticagrelor Plus Vorapaxar', 'description': 'Prasugrel or ticagrelor plus vorapaxar 2.5mg od\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nVorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'BG002', 'title': 'DAPT', 'description': 'Aspirin in addition to prasugrel or ticagrelor\n\nPrasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)\n\nAspirin: Aspirin will be administered at the dose of 81mg once daily\n\nTicagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '9', 'groupId': 'BG000'}, {'value': '56', 'spread': '9', 'groupId': 'BG001'}, {'value': '56', 'spread': '10', 'groupId': 'BG002'}, {'value': '56', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-30', 'size': 560873, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-07T16:05', 'hasProtocol': True}, {'date': '2018-07-05', 'size': 935682, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-07T16:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2015-09-08', 'resultsFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-10', 'studyFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Platelet Aggregation', 'timeFrame': '30 days', 'description': 'The primary end point of our study is the comparison of maximal platelet aggregation measured by light transmittance aggregometry using CAT (collagen-ADP-TRAP) between DAPT and DAPT plus vorapaxar after 30 days of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prasugrel', 'ticagrelor', 'vorapaxar'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '32306797', 'type': 'DERIVED', 'citation': 'Franchi F, Rollini F, Faz G, Rivas JR, Rivas A, Agarwal M, Briceno M, Wali M, Nawaz A, Silva G, Shaikh Z, Maaliki N, Fahmi K, Been L, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Baber U, Mehran R, Jennings LK, Bass TA, Angiolillo DJ. Pharmacodynamic Effects of Vorapaxar in Prior Myocardial Infarction Patients Treated With Potent Oral P2Y12 Receptor Inhibitors With and Without Aspirin: Results of the VORA-PRATIC Study. J Am Heart Assoc. 2020 Apr 21;9(8):e015865. doi: 10.1161/JAHA.120.015865. Epub 2020 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high, which may be in part due to the fact that other platelet signaling pathways, such as thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug Administration for the reduction of thrombotic cardiovascular events in patients with a history of MI or with peripheral arterial disease. However, to date clinical trial experience with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and the effects of vorapaxar in combination with antiplatelet therapy including prasugrel or ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a dual antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with withdrawal of aspirin, represents another important area of clinical interest as it has the potential to maximize ischemic protection while reducing the risk of bleeding. The proposed prospective, randomized, parallel-design, open label, study conducted in a real world clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor (prasugrel or ticagrelor) with and without aspirin.', 'detailedDescription': 'Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI). The novel P2Y12 receptor inhibitors prasugrel and ticagrelor are characterized by more prompt, potent, and predictable antiplatelet effects compared with clopidogrel and are associated with a greater reduction of ischemic events in acute coronary syndrome patients. However, rates of ischemic recurrences remain high, which may be in part due to the fact that other platelet signaling pathways, such as thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a novel, orally active, competitive and slowly reversible protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug Administration for the reduction of thrombotic cardiovascular events in patients with a history of MI or with peripheral arterial disease. A large-scale clinical trial showed that the use of vorapaxar (2.5 mg once/daily) in addition to standard antiplatelet therapy (including aspirin and a P2Y12 receptor inhibitor) was effective in the secondary prevention of recurrent thrombotic events in patients with previous atherothrombosis, in particular in patients with prior MI, at the expense of an increase in major bleeding. However, to date clinical trial experience with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and the effects of vorapaxar in combination with state-of-the-art antiplatelet therapy in the post-MI setting, including prasugrel or ticagrelor, is largely unexplored. This may indeed represent a limitation for the uptake of vorapaxar in modern day clinical practice where these agents are being more broadly utilized. Further, the role of vorapaxar as part of a dual antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with withdrawal of aspirin, represents another important area of clinical interest as it has the potential to maximize ischemic protection while reducing the risk of bleeding. The proposed prospective, randomized, parallel-design, open label, study conducted in a real world clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor (prasugrel or ticagrelor) with and without aspirin. Pharmacodynamic assessments will be performed at multiple time points and with different assays exploring multiple pathways of platelet aggregation. Exploratory assessments on the safety of such approach will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Patients with a prior MI within the previous 2 weeks to 12 months.\n2. On DAPT with low-dose aspirin (81mg od) and either prasugrel (10mg od) or ticagrelor (90mg bid) as per standard-of-care for at least 2 weeks.\n3. Free from bleeding and ischemic events after the index MI event.\n4. Age between 18 and 75 years old.\n\nExclusion criteria:\n\n1. History of stroke, transient ischemic attack, or intracranial hemorrhage.\n2. Active pathological bleeding, history of bleeding events or increased risk of bleeding.\n3. Known severe hepatic impairment.\n4. Age \\>75 years.\n5. Body weight \\<60 Kg.\n6. Use of strong Cytochrome P450 3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) or inducers (e.g., rifampin, carbamazepine, St. John's Wort and phenytoin).\n7. On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban).\n8. On treatment with any antiplatelet agent other than aspirin, prasugrel and ticagrelor in the past 14 days.\n9. Creatinine clearance \\<30 mL/minute.\n10. Platelet count \\<80x106/mL\n11. Hemoglobin \\<10g/dL\n12. Hemodynamic instability\n13. Pregnant females"}, 'identificationModule': {'nctId': 'NCT02545933', 'acronym': 'VORA-PRATIC', 'briefTitle': 'Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Adjunctive Vorapaxar Therapy in Patients With Prior Myocardial Infarction Treated With New Generation P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor (VORA-PRATIC): A Prospective, Randomized, Pharmacodynamic Study', 'orgStudyIdInfo': {'id': 'IIS 53376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAPT plus vorapaxar', 'description': 'Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od', 'interventionNames': ['Drug: Prasugrel', 'Drug: Vorapaxar', 'Drug: Aspirin', 'Drug: Ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel/ticagrelor plus vorapaxar', 'description': 'Prasugrel or ticagrelor plus vorapaxar 2.5mg od', 'interventionNames': ['Drug: Prasugrel', 'Drug: Vorapaxar', 'Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DAPT', 'description': 'Aspirin in addition to prasugrel or ticagrelor', 'interventionNames': ['Drug: Prasugrel', 'Drug: Aspirin', 'Drug: Ticagrelor']}], 'interventions': [{'name': 'Prasugrel', 'type': 'DRUG', 'otherNames': ['Effient'], 'description': 'Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)', 'armGroupLabels': ['DAPT', 'DAPT plus vorapaxar', 'Prasugrel/ticagrelor plus vorapaxar']}, {'name': 'Vorapaxar', 'type': 'DRUG', 'otherNames': ['Zontivity'], 'description': 'Vorapaxar will be administered at the dose of 2.5mg once daily', 'armGroupLabels': ['DAPT plus vorapaxar', 'Prasugrel/ticagrelor plus vorapaxar']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['ASA (acetylsalicylic acid)'], 'description': 'Aspirin will be administered at the dose of 81mg once daily', 'armGroupLabels': ['DAPT', 'DAPT plus vorapaxar']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilinta'], 'description': 'Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)', 'armGroupLabels': ['DAPT', 'DAPT plus vorapaxar', 'Prasugrel/ticagrelor plus vorapaxar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Dominick J Angiolillo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida College of Medicine-Jacksonville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}