Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

Myocardial Infarction Clinical Trial

— BRAVE-4  

Official title:

Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00976092
• Other study ID #: GE IDE I01209
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 11, 2009
• Last updated: January 6, 2014
• Start date: September 2009
• Est. completion date: February 2015

Study information

• Verified date: January 2014
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 548
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Prasugrel
60 mg prasugrel as loading dose prior to PPCI
• Bivalirudin
IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
• Clopidogrel
600 mg clopidogrel as loading dose before PPCI
• Heparin
i.v. bolus of 70-100 IU/kg body weight

Locations

Country	Name	City	State
Germany	Herzzentrum der Segeberger Kliniken	Bad Segeberg
Germany	Deutsches Herzzentrum Muenchen	Munich	Bavaria
Germany	Klinikum rechts der Isar, Technische Universitaet Muenchen	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding		30 days	Yes
Secondary	all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis		30 days	Yes
Secondary	major bleeding complications		30 days	Yes
Secondary	cardiac death		30 days	Yes