Design of the blockade of the glycoprotein IIb/IIIa receptor to avoid vascular occlusion (BRAVO) trial.
Abstract | BACKGROUND: METHODS:
Lotrafiban, a selective, nonpeptide antagonist of the human platelet fibrinogen receptor ( glycoprotein [ GP] IIb/IIIa [alphaIIb/ beta3 integrin]), blocks the binding of fibrinogen to the GP IIb/IIIa receptor, which is the final common pathway of platelet aggregation. Lotrafiban at doses of up to 50 mg twice daily was well-tolerated in a 12-week, double-blind, placebo-controlled, dose-ranging study in patients with recent myocardial infarction, unstable angina, transient ischemic attack, or stroke when added to aspirin therapy. On the basis of these results, a dosing regimen was selected for the phase III Blockage of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion ( BRAVO) trial based on pharmacodynamics and drug tolerability. In the pivotal BRAVO study, lotrafiban therapy is being evaluated in patients who have had a recent myocardial infarction, unstable angina, transient ischemic attack, or ischemic stroke, or who present at any time after a diagnosis of peripheral vascular disease combined with either cardiovascular or cerebrovascular disease. RESULTS: The efficacy evaluation will be based on a composite end point of clinical events (death by any cause, myocardial infarction, stroke, recurrent ischemia requiring hospitalization, or urgent ischemia-driven revascularization). The target enrollment is 9200 patients worldwide. Approximately 700 centers will participate and will be distributed within 30 countries across North America, Europe, Australia, and Asia.
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Authors | E J Topol, J D Easton, P Amarenco, R Califf, R Harrington, C Graffagnino, S Davis, H C Diener, J Ferguson, D Fitzgerald, A Shuaib, P J Koudstaal, P Theroux, F Van de Werf, J T Willerson, R Chan, R Samuels, B Ilson, J Granett |
Journal | American heart journal
(Am Heart J)
Vol. 139
Issue 6
Pg. 927-33
(Jun 2000)
ISSN: 0002-8703 [Print] United States |
PMID | 10827369
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Piperidines
- Platelet Aggregation Inhibitors
- Platelet Glycoprotein GPIIb-IIIa Complex
- Benzodiazepines
- lotrafiban
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Topics |
- Administration, Oral
- Adolescent
- Arterial Occlusive Diseases
(blood, prevention & control)
- Benzodiazepines
- Double-Blind Method
- Drug Evaluation
- Female
- Humans
- Ischemic Attack, Transient
(blood, drug therapy)
- Male
- Myocardial Infarction
(blood, prevention & control)
- Myocardial Ischemia
(blood, drug therapy)
- Piperidines
- Platelet Aggregation Inhibitors
(administration & dosage, therapeutic use)
- Platelet Glycoprotein GPIIb-IIIa Complex
(antagonists & inhibitors, metabolism)
- Research Design
- Secondary Prevention
- Stroke
(blood, prevention & control)
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