Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
BRAVE-4
Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI
1 other identifier
interventional
548
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2009
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJanuary 7, 2014
January 1, 2014
4.4 years
September 11, 2009
January 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
30 days
Secondary Outcomes (3)
all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis
30 days
major bleeding complications
30 days
cardiac death
30 days
Study Arms (2)
Prasugrel + Bivalirudin
EXPERIMENTAL60 mg prasugrel plus bivalirudin
Clopidogrel + Heparin
ACTIVE COMPARATORclopidogrel as loading and heparin
Interventions
60 mg prasugrel as loading dose prior to PPCI
IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
600 mg clopidogrel as loading dose before PPCI
i.v. bolus of 70-100 IU/kg body weight
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Deutsches Herzzentrum Muenchen
Munich, Bavaria, 80636, Germany
Klinikum rechts der Isar, Technische Universitaet Muenchen
Munich, Bavaria, 81674, Germany
Herzzentrum der Segeberger Kliniken
Bad Segeberg, 23795, Germany
Related Publications (2)
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.
PMID: 24816809DERIVEDSchulz 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.
PMID: 24633823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julinda Mehilli, MD
Deutsches Herzzentrum Muenchen
- STUDY CHAIR
Adnan Kastrati, MD
Deutsches Herzzentrum Muenchen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2014
Study Completion
February 1, 2015
Last Updated
January 7, 2014
Record last verified: 2014-01