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

January 6, 2014 updated by: Deutsches Herzzentrum Muenchen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

548

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Segeberg, Germany, 23795
        • Herzzentrum der Segeberger Kliniken
    • Bavaria
      • Munich, Bavaria, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Munich, Bavaria, Germany, 81674
        • Klinikum rechts der Isar, Technische Universitaet Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prasugrel + Bivalirudin
60 mg prasugrel plus bivalirudin
Drug: Prasugrel
60 mg prasugrel as loading dose prior to PPCI
Other Names:
  • Efient
Drug: Bivalirudin
IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
Other Names:
  • Angiox
Active Comparator: Clopidogrel + Heparin
clopidogrel as loading and heparin
Drug: Clopidogrel
600 mg clopidogrel as loading dose before PPCI
Other Names:
  • Plavix
Drug: Heparin
i.v. bolus of 70-100 IU/kg body weight
Other Names:
  • unfractionated Heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis
Time Frame: 30 days
30 days
major bleeding complications
Time Frame: 30 days
30 days
cardiac death
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
  • Principal Investigator: Julinda Mehilli, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE I01209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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