title: 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.
abstract: Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI). Effective and safe adjunct antithrombotic therapy is a major determinant for short- and long-term outcomes after primary PCI. Two separate studies have shown significant benefits vs conventional therapy for 2 recently approved drugs. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcome compared with heparin plus glycoprotein IIb/IIIa inhibitors. However, during the first 24 hours after PCI, there was an increase in stent thrombosis rates with bivalirudin. In the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial, prasugrel was superior to clopidogrel in patients with acute coronary syndrome with and without ST-segment elevation. The synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing primary PCI. However, no specifically designed studies have so far compared the combination of prasugrel plus bivalirudin with that of clopidogrel plus unfractionated heparin in these patients. The Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 study is a randomized, open-label, multicenter trial aimed to test the hypothesis that a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus unfractionated heparin in terms of net clinical outcome in STEMI patients with planned primary PCI.
authors.affiliation: German Heart Center Munich, Technical University, Munich, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Gershlick
authors.forename: Tanja
authors.initials: T
authors.lastname: Morath
authors.forename: Katharina
authors.initials: K
authors.lastname: Mayer
authors.forename: Julia
authors.initials: J
authors.lastname: Neudecker
authors.forename: Ralph
authors.initials: R
authors.lastname: Tölg
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.forename: Dieter
authors.initials: D
authors.lastname: Hauschke
authors.forename: Daniel
authors.initials: D
authors.lastname: Braun
authors.forename: Heribert
authors.initials: H
authors.lastname: Schunkert
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000601:surgery; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D000068799:Prasugrel Hydrochloride; D058921:Purinergic P2Y Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D010879:Piperazines; D058921:Purinergic P2Y Receptor Antagonists; D011994:Recombinant Proteins; D013876:Thiophenes; D006493:Heparin; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; C074619:bivalirudin