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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00976092
First received: September 11, 2009
Last updated: January 6, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 548
Study Start Date: September 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (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
Drug: Clopidogrel
600 mg clopidogrel as loading dose before PPCI
Other Name: Plavix
Drug: Heparin
i.v. bolus of 70-100 IU/kg body weight
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976092

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 6, 2014
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 August 01, 2014