Design of the blockade of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion (BRAVO) trial
Identifieur interne : 00C309 ( Main/Exploration ); précédent : 00C308; suivant : 00C310Design of the blockade of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion (BRAVO) trial
Auteurs : E. J. Topol [États-Unis] ; J. D. Easton [États-Unis] ; P. Amarenco [France] ; R. Califf [États-Unis] ; R. Harrington [États-Unis] ; C. Graffagnino [États-Unis] ; S. Davis [Australie] ; H. C. Diener [Allemagne] ; J. Ferguson [États-Unis] ; D. Fitzgerald [Irlande (pays)] ; A. Shuaib [Canada] ; P. J. Koudstaal [Pays-Bas] ; P. Theroux [Canada] ; F. Van De Werf [Belgique] ; J. T. Willerson [États-Unis] ; R. Chan [États-Unis] ; R. Samuels [États-Unis] ; B. Ilson [États-Unis] ; J. Granett [États-Unis]Source :
- The American heart journal [ 0002-8703 ] ; 2000.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Background Platelets play a key role in the pathogenesis of atherosclerosis, thrombosis, and acute coronary and cerebrovascular syndromes. Inhibition of platelet function by acetylsalicylic acid (aspirin) has been shown to reduce the incidence atherothrombotic events in patients with coronary, cerebrovascular, or peripheral vascular disease. Thienopyridine agents, however, including ticlopidine and clopidogrel, inhibit the adenosine diphosphate receptor and have modestly superior effects compared with aspirin on reduction of death, myocardial infarction, and stroke among a broad group of patients with vascular disease. More effective antithrombotic agents are still required to treat patients at high risk for recurrent vascular events. Methods Lotrafiban, a selective, nonpeptide antagonist of the human platelet fibrinogen receptor (glycoprotein [GP] IIb/IIIa [αIIb/β3 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.
Affiliations:
- Allemagne, Australie, Belgique, Canada, France, Irlande (pays), Pays-Bas, États-Unis
- Texas, Île-de-France
- Houston, Paris
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Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Design of the blockade of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion (BRAVO) trial</title>
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<author><name sortKey="Ilson, B" sort="Ilson, B" uniqKey="Ilson B" first="B." last="Ilson">B. Ilson</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>SmithKline Beecham Pharmaceuticals</s1>
<s2>Collegeville</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>SmithKline Beecham Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Granett, J" sort="Granett, J" uniqKey="Granett J" first="J." last="Granett">J. Granett</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>SmithKline Beecham Pharmaceuticals</s1>
<s2>Collegeville</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>SmithKline Beecham Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The American heart journal</title>
<title level="j" type="abbreviated">Am. heart j.</title>
<idno type="ISSN">0002-8703</idno>
<imprint><date when="2000">2000</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The American heart journal</title>
<title level="j" type="abbreviated">Am. heart j.</title>
<idno type="ISSN">0002-8703</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antagonist</term>
<term>Antiplatelet agent</term>
<term>Chemotherapy</term>
<term>Glycoprotein IIbIIIa</term>
<term>Human</term>
<term>Infarct</term>
<term>Myocardium</term>
<term>Stroke</term>
<term>Treatment</term>
<term>Treatment efficiency</term>
<term>Variant angina</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Infarctus</term>
<term>Myocarde</term>
<term>Angor instable</term>
<term>Accident cérébrovasculaire</term>
<term>Glycoprotéine IIbIIIa</term>
<term>Antagoniste</term>
<term>Chimiothérapie</term>
<term>Traitement</term>
<term>Efficacité traitement</term>
<term>Homme</term>
<term>Inhibiteur thromboagrégation</term>
<term>Lotrafiban</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background Platelets play a key role in the pathogenesis of atherosclerosis, thrombosis, and acute coronary and cerebrovascular syndromes. Inhibition of platelet function by acetylsalicylic acid (aspirin) has been shown to reduce the incidence atherothrombotic events in patients with coronary, cerebrovascular, or peripheral vascular disease. Thienopyridine agents, however, including ticlopidine and clopidogrel, inhibit the adenosine diphosphate receptor and have modestly superior effects compared with aspirin on reduction of death, myocardial infarction, and stroke among a broad group of patients with vascular disease. More effective antithrombotic agents are still required to treat patients at high risk for recurrent vascular events. Methods Lotrafiban, a selective, nonpeptide antagonist of the human platelet fibrinogen receptor (glycoprotein [GP] IIb/IIIa [αIIb/β3 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.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Pays-Bas</li>
<li>États-Unis</li>
</country>
<region><li>Texas</li>
<li>Île-de-France</li>
</region>
<settlement><li>Houston</li>
<li>Paris</li>
</settlement>
</list>
<tree><country name="États-Unis"><noRegion><name sortKey="Topol, E J" sort="Topol, E J" uniqKey="Topol E" first="E. J." last="Topol">E. J. Topol</name>
</noRegion>
<name sortKey="Califf, R" sort="Califf, R" uniqKey="Califf R" first="R." last="Califf">R. Califf</name>
<name sortKey="Chan, R" sort="Chan, R" uniqKey="Chan R" first="R." last="Chan">R. Chan</name>
<name sortKey="Easton, J D" sort="Easton, J D" uniqKey="Easton J" first="J. D." last="Easton">J. D. Easton</name>
<name sortKey="Ferguson, J" sort="Ferguson, J" uniqKey="Ferguson J" first="J." last="Ferguson">J. Ferguson</name>
<name sortKey="Graffagnino, C" sort="Graffagnino, C" uniqKey="Graffagnino C" first="C." last="Graffagnino">C. Graffagnino</name>
<name sortKey="Granett, J" sort="Granett, J" uniqKey="Granett J" first="J." last="Granett">J. Granett</name>
<name sortKey="Harrington, R" sort="Harrington, R" uniqKey="Harrington R" first="R." last="Harrington">R. Harrington</name>
<name sortKey="Ilson, B" sort="Ilson, B" uniqKey="Ilson B" first="B." last="Ilson">B. Ilson</name>
<name sortKey="Samuels, R" sort="Samuels, R" uniqKey="Samuels R" first="R." last="Samuels">R. Samuels</name>
<name sortKey="Willerson, J T" sort="Willerson, J T" uniqKey="Willerson J" first="J. T." last="Willerson">J. T. Willerson</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Amarenco, P" sort="Amarenco, P" uniqKey="Amarenco P" first="P." last="Amarenco">P. Amarenco</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Davis, S" sort="Davis, S" uniqKey="Davis S" first="S." last="Davis">S. Davis</name>
</noRegion>
</country>
<country name="Allemagne"><noRegion><name sortKey="Diener, H C" sort="Diener, H C" uniqKey="Diener H" first="H. C." last="Diener">H. C. Diener</name>
</noRegion>
</country>
<country name="Irlande (pays)"><noRegion><name sortKey="Fitzgerald, D" sort="Fitzgerald, D" uniqKey="Fitzgerald D" first="D." last="Fitzgerald">D. Fitzgerald</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Shuaib, A" sort="Shuaib, A" uniqKey="Shuaib A" first="A." last="Shuaib">A. Shuaib</name>
</noRegion>
<name sortKey="Theroux, P" sort="Theroux, P" uniqKey="Theroux P" first="P." last="Theroux">P. Theroux</name>
</country>
<country name="Pays-Bas"><noRegion><name sortKey="Koudstaal, P J" sort="Koudstaal, P J" uniqKey="Koudstaal P" first="P. J." last="Koudstaal">P. J. Koudstaal</name>
</noRegion>
</country>
<country name="Belgique"><noRegion><name sortKey="Van De Werf, F" sort="Van De Werf, F" uniqKey="Van De Werf F" first="F." last="Van De Werf">F. Van De Werf</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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