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

This study is currently recruiting participants.
Verified January 2012 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00976092
First received: September 11, 2009
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
 Drug: Prasugrel
Drug: Bivalirudin
Drug: Clopidogrel
Drug: Heparin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • major bleeding complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • cardiac death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1240
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel + Bivalirudin
60 mg prasugrel plus bivalirudin
 Drug: Prasugrel
60 mg prasugrel as loading dose prior to PPCI
Other Name: 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 Name: Angiox
Active Comparator: Clopidogrel + Heparin
clopidogrel as loading and heparin during PPCI
 Drug: Clopidogrel
600 mg clopidogrel as loading dose before PPCI
Other Name: Plavix
Drug: Heparin
i.v. bolus of 100 IE/body weight during PPCI
Other Name: unfractionated Heparin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 or clopidogrel
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976092

Contacts
Contact: Julinda Mehilli, MD +49-89-1218- ext 1534 mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD +49-89-1218- ext 1534 schulzs@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Bavaria, Germany, 80636
Contact: Julinda Mehilli, MD     +49-89-1218- ext 1534     mehilli@dhm.mhn.de    
Contact: Barbara Merzljak     +49-89-1218- ext 1534     merzljak@dhm.mhn.de    
Principal Investigator: Julinda Mehilli, MD            
Klinikum Rechts der Isar, Technische Universitaet Muenchen Recruiting
Munich, Bavaria, Germany, 81674
Contact: Josef Dirschinger, MD     +49-89-4140- ext 2948     dirschinger@med1.med.tu-muenchen.de    
Contact: Stefanie Schulz, MD     +49-89-1218- ext 1534     schulzs@dhm.mhn.de    
Principal Investigator: Josef Dirschinger, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00976092     History of Changes
Other Study ID Numbers: GE IDE I01209
Study First Received: September 11, 2009
Last Updated: January 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
myocardial infarction
clopidogrel
prasugrel
bivalirudin
primary PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Bivalirudin
Heparin
Hirudins
Ticlopidine
Clopidogrel
 Prasugrel
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 22, 2013