Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction (BRAVE-4)

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Heparin; Drug: Bivalirudin; Drug: Prasugrel; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00976092

GE IDE I01209

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 548 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients presenting within 24 hours from the onset of symptoms with STEMI
2. Informed, written consent
3. In women with childbearing potential a pregnancy test is obligatory.

Exclusion criteria

1. Age < 18 years
2. Cardiogenic shock
3. Active bleeding; bleeding diathesis; coagulopathy
4. History of gastrointestinal or genitourinary bleeding <2 months
5. Refusal to receive blood transfusion
6. Major surgery in the last 6 weeks
7. History of intracranial bleeding or structural abnormalities
8. Suspected aortic dissection
9. Heparin-induced thrombocytopenia
10. Any previous stroke
11. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
12. Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
13. Use of coumadin derivatives within the last 7 days
14. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel
15. Known malignancies or other comorbid conditions with life expectancy <1 year
16. Known severe liver disease, severe renal failure
17. Known allergy to the study medications
18. Previous enrollment in this trial
19. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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548 participants in 2 patient groups

Prasugrel + Bivalirudin

Experimental group

Description:

60 mg prasugrel plus bivalirudin

Treatment:

Drug: Prasugrel

Drug: Bivalirudin

Clopidogrel + Heparin

Active Comparator group

Description:

clopidogrel as loading and heparin

Treatment:

Drug: Clopidogrel

Drug: Heparin