Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-02 @ 12:54 AM
Study NCT ID:
NCT00976092
Status:
UNKNOWN
Last Update Posted:
2014-01-07
First Post:
2009-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C074619', 'term': 'bivalirudin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D006493', 'term': 'Heparin'}], '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': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 548}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2009-09-11', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis', 'timeFrame': '30 days'}, {'measure': 'major bleeding complications', 'timeFrame': '30 days'}, {'measure': 'cardiac death', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myocardial infarction', 'clopidogrel', 'prasugrel', 'bivalirudin', 'primary PCI'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '24816809', 'type': 'DERIVED', 'citation': 'Schulz S, Richardt G, Laugwitz KL, Morath T, Neudecker J, Hoppmann P, Mehran R, Gershlick AH, Tolg R, Anette Fiedler K, Abdel-Wahab M, Kufner S, Schneider S, Schunkert H, Ibrahim T, Mehilli J, Kastrati A; Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 Investigators. Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2014 Sep 7;35(34):2285-94. doi: 10.1093/eurheartj/ehu182. Epub 2014 May 9.'}, {'pmid': '24633823', 'type': 'DERIVED', 'citation': 'Schulz S, Richardt G, Laugwitz KL, Mehran R, Gershlick AH, Morath T, Mayer K, Neudecker J, Tolg R, Ibrahim T, Hauschke D, Braun D, Schunkert H, Kastrati A, Mehilli J; Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 Investigators. Comparison of prasugrel and bivalirudin vs clopidogrel and heparin in patients with ST-segment elevation myocardial infarction: Design and rationale of the Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 trial. Clin Cardiol. 2014 May;37(5):270-6. doi: 10.1002/clc.22268. Epub 2014 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheterization and coronary intervention.', 'detailedDescription': 'Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional anticoagulation therapy prior or during intervention plays an important role in the short- and long-term outcomes after PPCI. Two separate studies have shown significant benefit against conventional therapy based on clopidogrel and heparin for two recently approved drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. In the HORIZONS-AMI trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcomes. However, during the first 24 hours after PPCI an increase in the stent thrombosis rate was observed with bivalirudin therapy. Prasugrel has been shown to be superior to clopidogrel in patients with acute coronary syndromes undergoing PCI. The benefit in reduction of ischemic complication was even greater in the subset of patients with STEMI without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. Expectedly, the synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing PPCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients presenting within 24 hours from the onset of symptoms with STEMI\n2. Informed, written consent\n3. In women with childbearing potential a pregnancy test is obligatory.\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Cardiogenic shock\n3. Active bleeding; bleeding diathesis; coagulopathy\n4. History of gastrointestinal or genitourinary bleeding \\<2 months\n5. Refusal to receive blood transfusion\n6. Major surgery in the last 6 weeks\n7. History of intracranial bleeding or structural abnormalities\n8. Suspected aortic dissection\n9. Heparin-induced thrombocytopenia\n10. Any previous stroke\n11. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI\n12. Known relevant hematological deviations: Hb \\<100g/l, Thromb. \\<100x10\\^9/l\n13. Use of coumadin derivatives within the last 7 days\n14. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel\n15. Known malignancies or other comorbid conditions with life expectancy \\<1 year\n16. Known severe liver disease, severe renal failure\n17. Known allergy to the study medications\n18. Previous enrollment in this trial\n19. Pregnancy'}, 'identificationModule': {'nctId': 'NCT00976092', 'acronym': 'BRAVE-4', 'briefTitle': 'Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI', 'orgStudyIdInfo': {'id': 'GE IDE I01209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prasugrel + Bivalirudin', 'description': '60 mg prasugrel plus bivalirudin', 'interventionNames': ['Drug: Prasugrel', 'Drug: Bivalirudin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel + Heparin', 'description': 'clopidogrel as loading and heparin', 'interventionNames': ['Drug: Clopidogrel', 'Drug: Heparin']}], 'interventions': [{'name': 'Prasugrel', 'type': 'DRUG', 'otherNames': ['Efient'], 'description': '60 mg prasugrel as loading dose prior to PPCI', 'armGroupLabels': ['Prasugrel + Bivalirudin']}, {'name': 'Bivalirudin', 'type': 'DRUG', 'otherNames': ['Angiox'], 'description': 'IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI', 'armGroupLabels': ['Prasugrel + Bivalirudin']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': '600 mg clopidogrel as loading dose before PPCI', 'armGroupLabels': ['Clopidogrel + Heparin']}, {'name': 'Heparin', 'type': 'DRUG', 'otherNames': ['unfractionated Heparin'], 'description': 'i.v. bolus of 70-100 IU/kg body weight', 'armGroupLabels': ['Clopidogrel + Heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81674', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, Technische Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Herzzentrum der Segeberger Kliniken', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}], 'overallOfficials': [{'name': 'Julinda Mehilli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}, {'name': 'Adnan Kastrati, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}