drugset / Trial / NCT00976092
Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2014-02
- Completion
- 2015-02
Outcome
Missed primary endpoint
paper relative risk, 1.09; one-sided 97.5% confidence interval (CI) 0-1.79, P = 0.680 PMID 24816809 ↗
paper we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin. PMID 24816809 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | 1.75 mg/kg | Intravenous |
| Comparator | Clopidogrel | Small molecule | 600 mg | — |
| Comparator | Heparin | Other / unclassified | 70 iu/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | 100 iu/kg | Intravenous |
| Subject | Prasugrel | Small molecule | 60 mg | — |