Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial
Identifieur interne : 00B361 ( Main/Exploration ); précédent : 00B360; suivant : 00B362Design 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 [États-Unis] ; 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 :
- American Journal of Hypertension [ 0895-7061 ] ; 2002-02.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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 1 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.
Url:
DOI: 10.1016/S0895-7061(01)02048-9
Affiliations:
- Allemagne, Australie, Canada, Espagne, France, Irlande (pays), Italie, Royaume-Uni, Suède, États-Unis
- Communauté de Madrid, Illinois, New Jersey, Québec, Victoria (État), Écosse, État de New York, Île-de-France
- Chicago, Glasgow, Madrid, Melbourne, Montréal, New York, Paris
- Université de Glasgow
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Le document en format XML
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Kostis</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation><affiliation wicri:level="1"><country wicri:rule="url">États-Unis</country></affiliation><affiliation><wicri:noCountry code="syntax">???</wicri:noCountry></affiliation><affiliation wicri:level="1"><country wicri:rule="url">États-Unis</country></affiliation></author><author><name sortKey="Cobbe, Stuart" sort="Cobbe, Stuart" uniqKey="Cobbe S" first="Stuart" last="Cobbe">Stuart Cobbe</name><affiliation wicri:level="4"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Johnston, Colin" sort="Johnston, Colin" uniqKey="Johnston C" first="Colin" last="Johnston">Colin Johnston</name><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Baker Medical Research Institute, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name><affiliation wicri:level="4"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Murphy, Michael" sort="Murphy, Michael" uniqKey="Murphy M" first="Michael" last="Murphy">Michael Murphy</name><affiliation wicri:level="1"><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Cork University Hospital, Cork</wicri:regionArea><wicri:noRegion>Cork</wicri:noRegion></affiliation></author><author><name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A" last="Weber">Michael A. Weber</name><affiliation wicri:level="3"><country>États-Unis</country><placeName><settlement type="city">New York</settlement><region type="state">État de New York</region></placeName><wicri:orgArea>Bookdale Hospital Medical Center, Brooklyn</wicri:orgArea></affiliation></author><author><name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R" last="Black">Henry R. Black</name><affiliation wicri:level="3"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Rush-Presbyterian-St. Luke's Medical Center, Chicago</wicri:regionArea><placeName><settlement type="city">Chicago</settlement><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Plouin, Pierre Francois" sort="Plouin, Pierre Francois" uniqKey="Plouin P" first="Pierre Francois" last="Plouin">Pierre Francois Plouin</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Hôpital European Georges Pompidou, Paris</wicri:regionArea><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="Levy, Daniel" sort="Levy, Daniel" uniqKey="Levy D" first="Daniel" last="Levy">Daniel Levy</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Framingham Heart Study Institution, Framingham</wicri:regionArea><wicri:noRegion>Framingham</wicri:noRegion></affiliation></author><author><name sortKey="Mancia, Guiseppe" sort="Mancia, Guiseppe" uniqKey="Mancia G" first="Guiseppe" last="Mancia">Guiseppe Mancia</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Ospedale S. Gerardo dei Tintori, Monza</wicri:regionArea><wicri:noRegion>Monza</wicri:noRegion></affiliation></author><author><name sortKey="Larochelle, Pierre" sort="Larochelle, Pierre" uniqKey="Larochelle P" first="Pierre" last="Larochelle">Pierre Larochelle</name><affiliation wicri:level="3"><country xml:lang="fr">Canada</country><wicri:regionArea>Institut de Recherces Cliniques de Montreal, Montreal</wicri:regionArea><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Kolloch, Rainer E" sort="Kolloch, Rainer E" uniqKey="Kolloch R" first="Rainer E" last="Kolloch">Rainer E. Kolloch</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Wilhelms-Universitat, Bleiefeld</wicri:regionArea><wicri:noRegion>Bleiefeld</wicri:noRegion><wicri:noRegion>Bleiefeld</wicri:noRegion></affiliation></author><author><name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name><affiliation wicri:level="3"><country>États-Unis</country><placeName><settlement type="city">New York</settlement><region type="state">État de New York</region></placeName><wicri:orgArea>Albert Einstein College of Medicine, Bronx</wicri:orgArea></affiliation></author><author><name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name><affiliation wicri:level="3"><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Doce De Octubre, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Ostra University Hospital, Goteborg</wicri:regionArea><wicri:noRegion>Goteborg</wicri:noRegion></affiliation></author><author><name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M" last="Flack">John M. Flack</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Harper Hospital, Detroit</wicri:regionArea><wicri:noRegion>Detroit</wicri:noRegion></affiliation></author><author><name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton</wicri:regionArea><wicri:noRegion>Princeton</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">American Journal of Hypertension</title><title level="j" type="abbrev">AJH</title><idno type="ISSN">0895-7061</idno><idno type="eISSN">1941-7225</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2002-02">2002-02</date><biblScope unit="volume">15</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="193">193</biblScope><biblScope unit="page" to="198">198</biblScope></imprint><idno type="ISSN">0895-7061</idno></series></biblStruct></sourceDesc><seriesStmt><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>Isolated systolic hypertension</term><term>Omapatrilat</term><term>Prognosis</term><term>Treatment</term><term>cardiovascular morbidity and mortality</term><term>omapatrilat</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Antihypertenseur</term><term>Athérosclérose</term><term>Chimiothérapie</term><term>Homme</term><term>Hypertension artérielle</term><term>Omapatrilate</term><term>Pronostic</term><term>Traitement</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 1 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>Communauté de Madrid</li><li>Illinois</li><li>New Jersey</li><li>Québec</li><li>Victoria (État)</li><li>Écosse</li><li>État de New York</li><li>Île-de-France</li></region><settlement><li>Chicago</li><li>Glasgow</li><li>Madrid</li><li>Melbourne</li><li>Montréal</li><li>New York</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="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R" last="Black">Henry R. Black</name><name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M" last="Flack">John M. Flack</name><name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B" last="Kostis">John B. Kostis</name><name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B" last="Kostis">John B. Kostis</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"><region name="Victoria (État)"><name sortKey="Johnston, Colin" sort="Johnston, Colin" uniqKey="Johnston C" first="Colin" last="Johnston">Colin Johnston</name></region></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"><region name="Île-de-France"><name sortKey="Plouin, Pierre Francois" sort="Plouin, Pierre Francois" uniqKey="Plouin P" first="Pierre Francois" last="Plouin">Pierre Francois Plouin</name></region></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"><region name="Communauté de Madrid"><name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name></region></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>Pour manipuler ce document sous Unix (Dilib)
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