Back to resultsEfficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction (BRAVE-4)
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Prasugrel
Bivalirudin
Clopidogrel
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, clopidogrel, prasugrel, bivalirudin, primary PCI
Eligibility Criteria
Inclusion Criteria:
- Patients presenting within 24 hours from the onset of symptoms with STEMI
- Informed, written consent
- In women with childbearing potential a pregnancy test is obligatory.
Exclusion Criteria:
- Age < 18 years
- Cardiogenic shock
- Active bleeding; bleeding diathesis; coagulopathy
- History of gastrointestinal or genitourinary bleeding <2 months
- Refusal to receive blood transfusion
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
- Suspected aortic dissection
- Heparin-induced thrombocytopenia
- Any previous stroke
- Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
- Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
- Use of coumadin derivatives within the last 7 days
- Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel
- Known malignancies or other comorbid conditions with life expectancy <1 year
- Known severe liver disease, severe renal failure
- Known allergy to the study medications
- Previous enrollment in this trial
- Pregnancy
Sites / Locations
- Deutsches Herzzentrum Muenchen
- Klinikum rechts der Isar, Technische Universitaet Muenchen
- Herzzentrum der Segeberger Kliniken
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prasugrel + Bivalirudin
Clopidogrel + Heparin
Arm Description
60 mg prasugrel plus bivalirudin
clopidogrel as loading and heparin
Outcomes
Primary Outcome Measures
composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
Secondary Outcome Measures
all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis
major bleeding complications
cardiac death
Full Information
NCT ID
NCT00976092
First Posted
September 11, 2009
Last Updated
January 6, 2014
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT00976092
Brief Title
Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
Acronym
BRAVE-4
Official Title
Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, clopidogrel, prasugrel, bivalirudin, primary PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
548 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel + Bivalirudin
Arm Type
Experimental
Arm Description
60 mg prasugrel plus bivalirudin
Arm Title
Clopidogrel + Heparin
Arm Type
Active Comparator
Arm Description
clopidogrel as loading and heparin
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Efient
Intervention Description
60 mg prasugrel as loading dose prior to PPCI
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Angiox
Intervention Description
IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
600 mg clopidogrel as loading dose before PPCI
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
unfractionated Heparin
Intervention Description
i.v. bolus of 70-100 IU/kg body weight
Primary Outcome Measure Information:
Title
composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
Time Frame
30 days
Secondary Outcome Measure Information:
Title
all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis
Time Frame
30 days
Title
major bleeding complications
Time Frame
30 days
Title
cardiac death
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting within 24 hours from the onset of symptoms with STEMI
Informed, written consent
In women with childbearing potential a pregnancy test is obligatory.
Exclusion Criteria:
Age < 18 years
Cardiogenic shock
Active bleeding; bleeding diathesis; coagulopathy
History of gastrointestinal or genitourinary bleeding <2 months
Refusal to receive blood transfusion
Major surgery in the last 6 weeks
History of intracranial bleeding or structural abnormalities
Suspected aortic dissection
Heparin-induced thrombocytopenia
Any previous stroke
Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
Use of coumadin derivatives within the last 7 days
Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel
Known malignancies or other comorbid conditions with life expectancy <1 year
Known severe liver disease, severe renal failure
Known allergy to the study medications
Previous enrollment in this trial
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Facility Name
Klinikum rechts der Isar, Technische Universitaet Muenchen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81674
Country
Germany
Facility Name
Herzzentrum der Segeberger Kliniken
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24816809
Citation
Schulz S, Richardt G, Laugwitz KL, Morath T, Neudecker J, Hoppmann P, Mehran R, Gershlick AH, Tolg R, Anette Fiedler K, Abdel-Wahab M, Kufner S, Schneider S, Schunkert H, Ibrahim T, Mehilli J, Kastrati A; Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 Investigators. Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2014 Sep 7;35(34):2285-94. doi: 10.1093/eurheartj/ehu182. Epub 2014 May 9.
Results Reference
derived
PubMed Identifier
24633823
Citation
Schulz S, Richardt G, Laugwitz KL, Mehran R, Gershlick AH, Morath T, Mayer K, Neudecker J, Tolg R, Ibrahim T, Hauschke D, Braun D, Schunkert H, Kastrati A, Mehilli J; Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 Investigators. Comparison of prasugrel and bivalirudin vs clopidogrel and heparin in patients with ST-segment elevation myocardial infarction: Design and rationale of the Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 trial. Clin Cardiol. 2014 May;37(5):270-6. doi: 10.1002/clc.22268. Epub 2014 Mar 14.
Results Reference
derived
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Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
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