Design of the blockade of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion (BRAVO) trial
Identifieur interne : 005D23 ( PascalFrancis/Checkpoint ); précédent : 005D22; suivant : 005D24Design 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.
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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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Easton</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Rhode Island Hospital-Brown University</s1><s2>Providence</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Rhode Island Hospital-Brown University</wicri:noRegion></affiliation></author><author><name sortKey="Amarenco, P" sort="Amarenco, P" uniqKey="Amarenco P" first="P." last="Amarenco">P. Amarenco</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Hospital Lariboisiere</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Califf, R" sort="Califf, R" uniqKey="Califf R" first="R." last="Califf">R. Califf</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke Clinical Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Harrington, R" sort="Harrington, R" uniqKey="Harrington R" first="R." last="Harrington">R. Harrington</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke Clinical Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Graffagnino, C" sort="Graffagnino, C" uniqKey="Graffagnino C" first="C." last="Graffagnino">C. Graffagnino</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke Clinical Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Davis, S" sort="Davis, S" uniqKey="Davis S" first="S." last="Davis">S. Davis</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Royal Melbourne Hospital</s1><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Royal Melbourne Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Diener, H C" sort="Diener, H C" uniqKey="Diener H" first="H. C." last="Diener">H. C. Diener</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>University of Essen</s1><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Essen</wicri:noRegion><wicri:noRegion>University of Essen</wicri:noRegion></affiliation></author><author><name sortKey="Ferguson, J" sort="Ferguson, J" uniqKey="Ferguson J" first="J." last="Ferguson">J. Ferguson</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Texas Heart Institute</s1><s2>Houston</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Fitzgerald, D" sort="Fitzgerald, D" uniqKey="Fitzgerald D" first="D." last="Fitzgerald">D. Fitzgerald</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Royal College of Surgeons</s1><s2>Dublin</s2><s3>IRL</s3><sZ>10 aut.</sZ></inist:fA14><country>Irlande (pays)</country><wicri:noRegion>Royal College of Surgeons</wicri:noRegion></affiliation></author><author><name sortKey="Shuaib, A" sort="Shuaib, A" uniqKey="Shuaib A" first="A." last="Shuaib">A. Shuaib</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University of Alberta</s1><s3>CAN</s3><sZ>11 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Koudstaal, P J" sort="Koudstaal, P J" uniqKey="Koudstaal P" first="P. J." last="Koudstaal">P. J. Koudstaal</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University Hospital Rotterdam</s1><s3>NLD</s3><sZ>12 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>University Hospital Rotterdam</wicri:noRegion></affiliation></author><author><name sortKey="Theroux, P" sort="Theroux, P" uniqKey="Theroux P" first="P." last="Theroux">P. Theroux</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Institute de Cardiologie de Montreal</s1><s3>CAN</s3><sZ>13 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Institute de Cardiologie de Montreal</wicri:noRegion></affiliation></author><author><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><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>UZ Leuven-Gasthuisberg Interne Geneeskunde-Cardiologie</s1><s3>BEL</s3><sZ>14 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>UZ Leuven-Gasthuisberg Interne Geneeskunde-Cardiologie</wicri:noRegion></affiliation></author><author><name sortKey="Willerson, J T" sort="Willerson, J T" uniqKey="Willerson J" first="J. T." last="Willerson">J. T. Willerson</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>University of Texas Houston Medical School and Texas Heart Institute</s1><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Texas Houston Medical School and Texas Heart Institute</wicri:noRegion></affiliation></author><author><name sortKey="Chan, R" sort="Chan, R" uniqKey="Chan R" first="R." last="Chan">R. Chan</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="Samuels, R" sort="Samuels, R" uniqKey="Samuels R" first="R." last="Samuels">R. Samuels</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="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></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">00-0323583</idno><date when="2000">2000</date><idno type="stanalyst">PASCAL 00-0323583 INIST</idno><idno type="RBID">Pascal:00-0323583</idno><idno type="wicri:Area/PascalFrancis/Corpus">005F06</idno><idno type="wicri:Area/PascalFrancis/Curation">000264</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">005D23</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">005D23</idno></publicationStmt><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><author><name sortKey="Topol, E J" sort="Topol, E J" uniqKey="Topol E" first="E. J." last="Topol">E. J. Topol</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Cleveland Clinic</s1><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Cleveland Clinic</wicri:noRegion></affiliation></author><author><name sortKey="Easton, J D" sort="Easton, J D" uniqKey="Easton J" first="J. D." last="Easton">J. D. Easton</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Rhode Island Hospital-Brown University</s1><s2>Providence</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Rhode Island Hospital-Brown University</wicri:noRegion></affiliation></author><author><name sortKey="Amarenco, P" sort="Amarenco, P" uniqKey="Amarenco P" first="P." last="Amarenco">P. Amarenco</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Hospital Lariboisiere</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Califf, R" sort="Califf, R" uniqKey="Califf R" first="R." last="Califf">R. Califf</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke Clinical Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Harrington, R" sort="Harrington, R" uniqKey="Harrington R" first="R." last="Harrington">R. Harrington</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke Clinical Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Graffagnino, C" sort="Graffagnino, C" uniqKey="Graffagnino C" first="C." last="Graffagnino">C. Graffagnino</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke Clinical Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Davis, S" sort="Davis, S" uniqKey="Davis S" first="S." last="Davis">S. Davis</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Royal Melbourne Hospital</s1><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Royal Melbourne Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Diener, H C" sort="Diener, H C" uniqKey="Diener H" first="H. C." last="Diener">H. C. Diener</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>University of Essen</s1><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Essen</wicri:noRegion><wicri:noRegion>University of Essen</wicri:noRegion></affiliation></author><author><name sortKey="Ferguson, J" sort="Ferguson, J" uniqKey="Ferguson J" first="J." last="Ferguson">J. Ferguson</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Texas Heart Institute</s1><s2>Houston</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Fitzgerald, D" sort="Fitzgerald, D" uniqKey="Fitzgerald D" first="D." last="Fitzgerald">D. Fitzgerald</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Royal College of Surgeons</s1><s2>Dublin</s2><s3>IRL</s3><sZ>10 aut.</sZ></inist:fA14><country>Irlande (pays)</country><wicri:noRegion>Royal College of Surgeons</wicri:noRegion></affiliation></author><author><name sortKey="Shuaib, A" sort="Shuaib, A" uniqKey="Shuaib A" first="A." last="Shuaib">A. Shuaib</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University of Alberta</s1><s3>CAN</s3><sZ>11 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Koudstaal, P J" sort="Koudstaal, P J" uniqKey="Koudstaal P" first="P. J." last="Koudstaal">P. J. Koudstaal</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University Hospital Rotterdam</s1><s3>NLD</s3><sZ>12 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>University Hospital Rotterdam</wicri:noRegion></affiliation></author><author><name sortKey="Theroux, P" sort="Theroux, P" uniqKey="Theroux P" first="P." last="Theroux">P. Theroux</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Institute de Cardiologie de Montreal</s1><s3>CAN</s3><sZ>13 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Institute de Cardiologie de Montreal</wicri:noRegion></affiliation></author><author><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><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>UZ Leuven-Gasthuisberg Interne Geneeskunde-Cardiologie</s1><s3>BEL</s3><sZ>14 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>UZ Leuven-Gasthuisberg Interne Geneeskunde-Cardiologie</wicri:noRegion></affiliation></author><author><name sortKey="Willerson, J T" sort="Willerson, J T" uniqKey="Willerson J" first="J. T." last="Willerson">J. T. Willerson</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>University of Texas Houston Medical School and Texas Heart Institute</s1><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Texas Houston Medical School and Texas Heart Institute</wicri:noRegion></affiliation></author><author><name sortKey="Chan, R" sort="Chan, R" uniqKey="Chan R" first="R." last="Chan">R. Chan</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="Samuels, R" sort="Samuels, R" uniqKey="Samuels R" first="R." last="Samuels">R. Samuels</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="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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0002-8703</s0></fA01><fA02 i1="01"><s0>AHJOA2</s0></fA02><fA03 i2="1"><s0>Am. heart j.</s0></fA03><fA05><s2>139</s2></fA05><fA06><s2>6</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Design of the blockade of the Glycoprotein IIb/IIIa Receptor to Avoid Vascular Occlusion (BRAVO) trial</s1></fA08><fA11 i1="01" i2="1"><s1>TOPOL (E. J.)</s1></fA11><fA11 i1="02" i2="1"><s1>EASTON (J. D.)</s1></fA11><fA11 i1="03" i2="1"><s1>AMARENCO (P.)</s1></fA11><fA11 i1="04" i2="1"><s1>CALIFF (R.)</s1></fA11><fA11 i1="05" i2="1"><s1>HARRINGTON (R.)</s1></fA11><fA11 i1="06" i2="1"><s1>GRAFFAGNINO (C.)</s1></fA11><fA11 i1="07" i2="1"><s1>DAVIS (S.)</s1></fA11><fA11 i1="08" i2="1"><s1>DIENER (H. C.)</s1></fA11><fA11 i1="09" i2="1"><s1>FERGUSON (J.)</s1></fA11><fA11 i1="10" i2="1"><s1>FITZGERALD (D.)</s1></fA11><fA11 i1="11" i2="1"><s1>SHUAIB (A.)</s1></fA11><fA11 i1="12" i2="1"><s1>KOUDSTAAL (P. J.)</s1></fA11><fA11 i1="13" i2="1"><s1>THEROUX (P.)</s1></fA11><fA11 i1="14" i2="1"><s1>VAN DE WERF (F.)</s1></fA11><fA11 i1="15" i2="1"><s1>WILLERSON (J. T.)</s1></fA11><fA11 i1="16" i2="1"><s1>CHAN (R.)</s1></fA11><fA11 i1="17" i2="1"><s1>SAMUELS (R.)</s1></fA11><fA11 i1="18" i2="1"><s1>ILSON (B.)</s1></fA11><fA11 i1="19" i2="1"><s1>GRANETT (J.)</s1></fA11><fA14 i1="01"><s1>Cleveland Clinic</s1><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Rhode Island Hospital-Brown University</s1><s2>Providence</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Hospital Lariboisiere</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Duke Clinical Research Institute</s1><s2>Durham</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ></fA14><fA14 i1="05"><s1>Royal Melbourne Hospital</s1><s3>AUS</s3><sZ>7 aut.</sZ></fA14><fA14 i1="06"><s1>University of Essen</s1><s3>DEU</s3><sZ>8 aut.</sZ></fA14><fA14 i1="07"><s1>Texas Heart Institute</s1><s2>Houston</s2><s3>USA</s3><sZ>9 aut.</sZ></fA14><fA14 i1="08"><s1>Royal College of Surgeons</s1><s2>Dublin</s2><s3>IRL</s3><sZ>10 aut.</sZ></fA14><fA14 i1="09"><s1>University of Alberta</s1><s3>CAN</s3><sZ>11 aut.</sZ></fA14><fA14 i1="10"><s1>University Hospital Rotterdam</s1><s3>NLD</s3><sZ>12 aut.</sZ></fA14><fA14 i1="11"><s1>Institute de Cardiologie de Montreal</s1><s3>CAN</s3><sZ>13 aut.</sZ></fA14><fA14 i1="12"><s1>UZ Leuven-Gasthuisberg Interne Geneeskunde-Cardiologie</s1><s3>BEL</s3><sZ>14 aut.</sZ></fA14><fA14 i1="13"><s1>University of Texas Houston Medical School and Texas Heart Institute</s1><s3>USA</s3><sZ>15 aut.</sZ></fA14><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></fA14><fA20><s1>927-933</s1></fA20><fA21><s1>2000</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>2057</s2><s5>354000082511680010</s5></fA43><fA44><s0>0000</s0><s1>© 2000 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>20 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>00-0323583</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>The American heart journal</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B02G</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Infarctus</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Infarct</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Infarto</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Myocarde</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Myocardium</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Miocardio</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Angor instable</s0><s5>04</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Variant angina</s0><s5>04</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Angina inestable</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Accident cérébrovasculaire</s0><s5>07</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Stroke</s0><s5>07</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Accidente cerebrovascular</s0><s5>07</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Glycoprotéine IIbIIIa</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Glycoprotein IIbIIIa</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Glicoproteína IIbIIIa</s0><s5>10</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Antagoniste</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Antagonist</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Antagonista</s0><s5>11</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Chimiothérapie</s0><s5>16</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Chemotherapy</s0><s5>16</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Quimioterapia</s0><s5>16</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Traitement</s0><s5>17</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Treatment</s0><s5>17</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Tratamiento</s0><s5>17</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Efficacité traitement</s0><s5>18</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Treatment efficiency</s0><s5>18</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Eficacia tratamiento</s0><s5>18</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Homme</s0><s5>20</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Human</s0><s5>20</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Hombre</s0><s5>20</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Inhibiteur thromboagrégation</s0><s5>31</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Antiplatelet agent</s0><s5>31</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Inhibidor tromboagregación</s0><s5>31</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Lotrafiban</s0><s2>FR</s2><s4>INC</s4><s5>86</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Appareil circulatoire pathologie</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cardiovascular disease</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Aparato circulatorio patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Cardiopathie coronaire</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Coronary heart disease</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Cardiopatía coronaria</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Myocarde pathologie</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Myocardial disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Miocardio patología</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Système nerveux pathologie</s0><s5>53</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>53</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>53</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0><s5>54</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>54</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>54</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Encéphale pathologie</s0><s5>55</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>55</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>55</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Cérébrovasculaire pathologie</s0><s5>56</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Cerebrovascular disease</s0><s5>56</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Vaso sanguíneo encéfalo patología</s0><s5>56</s5></fC07><fC07 i1="08" i2="X" l="FRE"><s0>Vaisseau sanguin pathologie</s0><s5>58</s5></fC07><fC07 i1="08" i2="X" l="ENG"><s0>Vascular disease</s0><s5>58</s5></fC07><fC07 i1="08" i2="X" l="SPA"><s0>Vaso sanguíneo patología</s0><s5>58</s5></fC07><fN21><s1>220</s1></fN21></pA></standard></inist><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>Pour manipuler ce document sous Unix (Dilib)
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