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Design of the Omapatrilat in Persons with Enhanced Risk of atherosclerotic events (OPERA) trial

Identifieur interne : 002217 ( Main/Merge ); précédent : 002216; suivant : 002218

Design of the Omapatrilat in Persons with Enhanced Risk of atherosclerotic events (OPERA) trial

Auteurs : John B. Kostis [États-Unis] ; Stuart Cobbe [Royaume-Uni] ; Colin Johnston [Australie] ; Ian Ford [Royaume-Uni] ; Michael Murphy [Irlande (pays)] ; Michael A. Weber [États-Unis] ; Henry R. Black [France] ; Pierre Francois Plouin [France] ; Daniel Levy [États-Unis] ; Guiseppe Mancia [Italie] ; Pierre Larochelle [Canada] ; Rainer E. Kolloch [Allemagne] ; Michael Alderman [États-Unis] ; Luis Miguel Ruilope [Espagne] ; Björn Dahlöf [Suède] ; John M. Flack [États-Unis] ; Robert Wolf [États-Unis]

Source :

RBID : Pascal:02-0201829

Descripteurs français

English descriptors

Abstract

The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage I ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction. fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.

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Pascal:02-0201829

Le document en format XML

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<name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name>
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<title level="j" type="main">American journal of hypertension</title>
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<seriesStmt>
<title level="j" type="main">American journal of hypertension</title>
<title level="j" type="abbreviated">Am. j. hypertens.</title>
<idno type="ISSN">0895-7061</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Antihypertensive agent</term>
<term>Atherosclerosis</term>
<term>Chemotherapy</term>
<term>Human</term>
<term>Hypertension</term>
<term>Omapatrilat</term>
<term>Prognosis</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Athérosclérose</term>
<term>Hypertension artérielle</term>
<term>Omapatrilate</term>
<term>Chimiothérapie</term>
<term>Traitement</term>
<term>Pronostic</term>
<term>Homme</term>
<term>Antihypertenseur</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage I ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction. fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Suède</li>
<li>États-Unis</li>
</country>
<region>
<li>Massachusetts</li>
<li>Michigan</li>
<li>New Jersey</li>
<li>Québec</li>
<li>Écosse</li>
<li>État de New York</li>
</region>
<settlement>
<li>Glasgow</li>
<li>Montréal</li>
<li>Paris</li>
</settlement>
<orgName>
<li>Université de Glasgow</li>
</orgName>
</list>
<tree>
<country name="États-Unis">
<region name="New Jersey">
<name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B." last="Kostis">John B. Kostis</name>
</region>
<name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name>
<name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M." last="Flack">John M. Flack</name>
<name sortKey="Levy, Daniel" sort="Levy, Daniel" uniqKey="Levy D" first="Daniel" last="Levy">Daniel Levy</name>
<name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A." last="Weber">Michael A. Weber</name>
<name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name>
</country>
<country name="Royaume-Uni">
<region name="Écosse">
<name sortKey="Cobbe, Stuart" sort="Cobbe, Stuart" uniqKey="Cobbe S" first="Stuart" last="Cobbe">Stuart Cobbe</name>
</region>
<name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Johnston, Colin" sort="Johnston, Colin" uniqKey="Johnston C" first="Colin" last="Johnston">Colin Johnston</name>
</noRegion>
</country>
<country name="Irlande (pays)">
<noRegion>
<name sortKey="Murphy, Michael" sort="Murphy, Michael" uniqKey="Murphy M" first="Michael" last="Murphy">Michael Murphy</name>
</noRegion>
</country>
<country name="France">
<noRegion>
<name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R." last="Black">Henry R. Black</name>
</noRegion>
<name sortKey="Plouin, Pierre Francois" sort="Plouin, Pierre Francois" uniqKey="Plouin P" first="Pierre Francois" last="Plouin">Pierre Francois Plouin</name>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Mancia, Guiseppe" sort="Mancia, Guiseppe" uniqKey="Mancia G" first="Guiseppe" last="Mancia">Guiseppe Mancia</name>
</noRegion>
</country>
<country name="Canada">
<region name="Québec">
<name sortKey="Larochelle, Pierre" sort="Larochelle, Pierre" uniqKey="Larochelle P" first="Pierre" last="Larochelle">Pierre Larochelle</name>
</region>
</country>
<country name="Allemagne">
<noRegion>
<name sortKey="Kolloch, Rainer E" sort="Kolloch, Rainer E" uniqKey="Kolloch R" first="Rainer E." last="Kolloch">Rainer E. Kolloch</name>
</noRegion>
</country>
<country name="Espagne">
<noRegion>
<name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name>
</noRegion>
</country>
<country name="Suède">
<noRegion>
<name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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