Trial DesignDesign of the Blockade of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion (BRAVO) trial☆,☆☆
Section snippets
Study design
This is a randomized, placebo-controlled, double-blind, 2-arm, parallel group study with the duration determined by the incidence rate of clinical events. Analysis will be performed when at least 1345 patients have had clinical events, of which at least 811 patients must have died or had a stroke or MI. All patients will be encouraged to remain taking study medication for the duration of the study. Patients are to receive lotrafiban combined with aspirin or placebo combined with aspirin for at
Study conduct
There is a screening period followed by baseline evaluation and initiation of therapy (Figure 1).The length of the on-therapy period will be determined by the incidence of clinical events but will be at least 6 months (except for patients who have an end point clinical event of death before 6 months of therapy) and up to 2 years with further extensions possible. Patients who are discontinued from study medication remain in the study and will undergo all scheduled visits
Discussion
Platelets play a key role in the pathogenesis of atherosclerosis, thrombosis, and acute coronary syndromes. Atherothrombosis is a chronic process involving formation of a platelet-rich thrombus in an atherosclerotic artery. The most commonly recognized sequelae of atherothrombosis are also the most common causes of death in developed countries: acute MI and ischemic stroke. Other consequences include TIA, unstable angina, progressive claudication, acute limb ischemia, and amputation.
References (20)
- et al.
The ESPS II trial
J Neurol Sci
(1996) - et al.
Randomized trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months
Lancet
(1994) - et al.
Platelet GP IIb/IIIa blockers
Lancet
(1999) - et al.
Platelet-surface interactions
- et al.
The pathogenesis of coronary artery disease and acute coronary syndromes
N Engl J Med
(1992) Collaborative overview of randomized trials of antiplatelet therapy. I: prevention of death, myocardial infarction and stroke by prolonged antiplatelet therapy in various categories of patients
BMJ
(1994)Collaborative overview of randomized trials of antiplatelet therapy. I: Prevention of death, myocardial infarction and stroke by prolonged antiplatelet therapy in various categories of patients
BMJ
(1994)Collaborative overview of randomized trials of antiplatelet therapy. I: Prevention of death, myocardial infarction and stroke by prolonged antiplatelet therapy in various categories of patients
BMJ
(1994)- et al.
A randomized, blinded, trial of Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE)
Lancet
(1996) - et al.
Characterization of a functional thrombin receptor: issues and opportunities
J Clin Invest
(1992)
Cited by (0)
- ☆
Supported by SmithKline Beecham.
- ☆☆
Reprint requests: Eric J. Topol, MD, Department of Cardiology, The Cleveland Clinic Foundation, 9500 Euclid Ave, F-25, Cleveland, Ohio 44195. E-mail: [email protected]