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

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ClinicalTrials.gov Identifier: NCT00976092
Recruitment Status : Unknown
Verified January 2014 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2009
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Prasugrel Drug: Bivalirudin Drug: Clopidogrel Drug: Heparin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 548 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI
Study Start Date : September 2009
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis [ Time Frame: 30 days ]
  2. major bleeding complications [ Time Frame: 30 days ]
  3. cardiac death [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976092

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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
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Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00976092    
Other Study ID Numbers: GE IDE I01209
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by Deutsches Herzzentrum Muenchen:
myocardial infarction
primary PCI
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors