drugset / Trial / NCT01158846
Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
Phase 4
Unknown
800 enrolled
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Azienda Ospedaliera Niguarda Cà Granda · collabCentro Cardiologico Monzino · collabIstituto Clinico Humanitas · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-06
- Completion
- 2011-06
Publications
- Background Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4.
- Background Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abciximab | Monoclonal antibody | — | — |
| Comparator | Bivalirudin | Peptide | — | — |
| Comparator | Clopidogrel | Small molecule | 75 mg | — |
| Comparator | Prasugrel | Small molecule | 5 mg | — |
| Comparator | Prasugrel | Small molecule | 10 mg | — |