OperaV1, PascalFrancis, Curation, bibRecord, 000084

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

Identifieur interne : 000084 ( PascalFrancis/Curation ); précédent : 000083; suivant : 000085

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 :

American journal of hypertension [ 0895-7061 ] ; 2002.

RBID : Pascal:02-0201829

Descripteurs français

Pascal (Inist)
- Athérosclérose, Hypertension artérielle, Omapatrilate, Chimiothérapie, Traitement, Pronostic, Homme, Antihypertenseur.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Antihypertensive agent, Atherosclerosis, Chemotherapy, Human, Hypertension, Omapatrilat, Prognosis, Treatment.

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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A03		`1`		`@0 Am. j. hypertens.`
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A08	`01`	`1`	`ENG`	`@1 Design of the Omapatrilat in Persons with Enhanced Risk of atherosclerotic events (OPERA) trial`
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A11	`02`	`1`		`@1 COBBE (Stuart)`
A11	`03`	`1`		`@1 JOHNSTON (Colin)`
A11	`04`	`1`		`@1 FORD (Ian)`
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A11	`12`	`1`		`@1 KOLLOCH (Rainer E.)`
A11	`13`	`1`		`@1 ALDERMAN (Michael)`
A11	`14`	`1`		`@1 RUILOPE (Luis Miguel)`
A11	`15`	`1`		`@1 DAHLÖF (Björn)`
A11	`16`	`1`		`@1 FLACK (John M.)`
A11	`17`	`1`		`@1 WOLF (Robert)`
A14	`01`			`@1 University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School @2 New Brunswick, New Jersey @3 USA @Z 1 aut.`
A14	`02`			`@1 University of Glasgow @2 Glasgow, Scotland @3 GBR @Z 2 aut. @Z 4 aut.`
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A14	`09`			`@1 Ospedale S. Gerardo dei Tintori @2 Monza @3 ITA @Z 10 aut.`
A14	`10`			`@1 Institut de Recherces Cliniques de Montreal @2 Montreal @3 CAN @Z 11 aut.`
A14	`11`			`@1 Wilhelms-Universitat @2 Bleiefeld @3 DEU @Z 12 aut.`
A14	`12`			`@1 Albert Einstein College of Medicine @2 Bronx, New York @3 USA @Z 13 aut.`
A14	`13`			`@1 Hospital Doce De Octubre @2 Madrid @3 ESP @Z 14 aut.`
A14	`14`			`@1 Ostra University Hospital @2 Goteborg @3 SWE @Z 15 aut.`
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C01	`01`		`ENG`	@0 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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C03	`03`	`X`	`FRE`	`@0 Omapatrilate @2 NK @2 FR @5 07`
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C03	`08`	`X`	`FRE`	`@0 Antihypertenseur @5 29`
C03	`08`	`X`	`ENG`	`@0 Antihypertensive agent @5 29`
C03	`08`	`X`	`SPA`	`@0 Antihipertensivo @5 29`
C07	`01`	`X`	`FRE`	`@0 Appareil circulatoire pathologie @5 37`
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C07	`02`	`X`	`SPA`	`@0 Vaso sanguíneo patología @5 38`
N21				`@1 119`
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Le document en format XML

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<author><name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B." last="Kostis">John B. Kostis</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School</s1>
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<author><name sortKey="Murphy, Michael" sort="Murphy, Michael" uniqKey="Murphy M" first="Michael" last="Murphy">Michael Murphy</name>
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<author><name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A." last="Weber">Michael A. Weber</name>
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<author><name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R." last="Black">Henry R. Black</name>
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<author><name sortKey="Plouin, Pierre Francois" sort="Plouin, Pierre Francois" uniqKey="Plouin P" first="Pierre Francois" last="Plouin">Pierre Francois Plouin</name>
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<author><name sortKey="Levy, Daniel" sort="Levy, Daniel" uniqKey="Levy D" first="Daniel" last="Levy">Daniel Levy</name>
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<author><name sortKey="Mancia, Guiseppe" sort="Mancia, Guiseppe" uniqKey="Mancia G" first="Guiseppe" last="Mancia">Guiseppe Mancia</name>
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<author><name sortKey="Larochelle, Pierre" sort="Larochelle, Pierre" uniqKey="Larochelle P" first="Pierre" last="Larochelle">Pierre Larochelle</name>
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<country>Canada</country>
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<author><name sortKey="Kolloch, Rainer E" sort="Kolloch, Rainer E" uniqKey="Kolloch R" first="Rainer E." last="Kolloch">Rainer E. Kolloch</name>
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<country>Allemagne</country>
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<author><name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name>
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<author><name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name>
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<s3>ESP</s3>
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</inist:fA14>
<country>Espagne</country>
</affiliation>
</author>
<author><name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name>
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<country>Suède</country>
</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"><inist:fA14 i1="15"><s1>Harper Hospital</s1>
<s2>Detroit, Michigan</s2>
<s3>USA</s3>
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</author>
<author><name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name>
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<s2>Princeton, New Jersey</s2>
<s3>USA</s3>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Design of the Omapatrilat in Persons with Enhanced Risk of atherosclerotic events (OPERA) trial</title>
<author><name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B." last="Kostis">John B. Kostis</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School</s1>
<s2>New Brunswick, New Jersey</s2>
<s3>USA</s3>
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</inist:fA14>
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</affiliation>
</author>
<author><name sortKey="Cobbe, Stuart" sort="Cobbe, Stuart" uniqKey="Cobbe S" first="Stuart" last="Cobbe">Stuart Cobbe</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>University of Glasgow</s1>
<s2>Glasgow, Scotland</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
</author>
<author><name sortKey="Johnston, Colin" sort="Johnston, Colin" uniqKey="Johnston C" first="Colin" last="Johnston">Colin Johnston</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Baker Medical Research Institute</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
</author>
<author><name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>University of Glasgow</s1>
<s2>Glasgow, Scotland</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
</author>
<author><name sortKey="Murphy, Michael" sort="Murphy, Michael" uniqKey="Murphy M" first="Michael" last="Murphy">Michael Murphy</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Cork University Hospital</s1>
<s2>Cork</s2>
<s3>IRL</s3>
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</inist:fA14>
<country>Irlande (pays)</country>
</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="1"><inist:fA14 i1="05"><s1>Bookdale Hospital Medical Center</s1>
<s2>Brooklyn, New York</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</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="1"><inist:fA14 i1="06"><s1>Rush-Presbyterian-St. Luke's Medical Center</s1>
<s2>Chicago, Illinois</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>France</country>
</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="1"><inist:fA14 i1="07"><s1>Hôpital European Georges Pompidou</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Levy, Daniel" sort="Levy, Daniel" uniqKey="Levy D" first="Daniel" last="Levy">Daniel Levy</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Framingham Heart Study Institution</s1>
<s2>Framingham, Massachusetts</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Mancia, Guiseppe" sort="Mancia, Guiseppe" uniqKey="Mancia G" first="Guiseppe" last="Mancia">Guiseppe Mancia</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Ospedale S. Gerardo dei Tintori</s1>
<s2>Monza</s2>
<s3>ITA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="Larochelle, Pierre" sort="Larochelle, Pierre" uniqKey="Larochelle P" first="Pierre" last="Larochelle">Pierre Larochelle</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Institut de Recherces Cliniques de Montreal</s1>
<s2>Montreal</s2>
<s3>CAN</s3>
<sZ>11 aut.</sZ>
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<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"><inist:fA14 i1="11"><s1>Wilhelms-Universitat</s1>
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<s3>DEU</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
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</author>
<author><name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Albert Einstein College of Medicine</s1>
<s2>Bronx, New York</s2>
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<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</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="1"><inist:fA14 i1="13"><s1>Hospital Doce De Octubre</s1>
<s2>Madrid</s2>
<s3>ESP</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
</affiliation>
</author>
<author><name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name>
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<s3>SWE</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Suède</country>
</affiliation>
</author>
<author><name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M." last="Flack">John M. Flack</name>
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<s2>Detroit, Michigan</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
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<country>États-Unis</country>
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</author>
<author><name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Bristol-Myers Squibb</s1>
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<series><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>
<imprint><date when="2002">2002</date>
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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>
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<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>
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<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>
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</fA11>
<fA11 i1="05" i2="1"><s1>MURPHY (Michael)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>WEBER (Michael A.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>BLACK (Henry R.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>PLOUIN (Pierre Francois)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>LEVY (Daniel)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>MANCIA (Guiseppe)</s1>
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<fA11 i1="11" i2="1"><s1>LAROCHELLE (Pierre)</s1>
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<fA11 i1="12" i2="1"><s1>KOLLOCH (Rainer E.)</s1>
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<fA11 i1="16" i2="1"><s1>FLACK (John M.)</s1>
</fA11>
<fA11 i1="17" i2="1"><s1>WOLF (Robert)</s1>
</fA11>
<fA14 i1="01"><s1>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School</s1>
<s2>New Brunswick, New Jersey</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>University of Glasgow</s1>
<s2>Glasgow, Scotland</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Baker Medical Research Institute</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Cork University Hospital</s1>
<s2>Cork</s2>
<s3>IRL</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Bookdale Hospital Medical Center</s1>
<s2>Brooklyn, New York</s2>
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<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Rush-Presbyterian-St. Luke's Medical Center</s1>
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<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Hôpital European Georges Pompidou</s1>
<s2>Paris</s2>
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<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Framingham Heart Study Institution</s1>
<s2>Framingham, Massachusetts</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Ospedale S. Gerardo dei Tintori</s1>
<s2>Monza</s2>
<s3>ITA</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Institut de Recherces Cliniques de Montreal</s1>
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<s3>CAN</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Wilhelms-Universitat</s1>
<s2>Bleiefeld</s2>
<s3>DEU</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Albert Einstein College of Medicine</s1>
<s2>Bronx, New York</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Hospital Doce De Octubre</s1>
<s2>Madrid</s2>
<s3>ESP</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>Ostra University Hospital</s1>
<s2>Goteborg</s2>
<s3>SWE</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Harper Hospital</s1>
<s2>Detroit, Michigan</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="16"><s1>Bristol-Myers Squibb</s1>
<s2>Princeton, New Jersey</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>OPERA Study Group</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>193-198</s1>
</fA20>
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</fA60>
<fA61><s0>A</s0>
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<fA64 i1="01" i2="1"><s0>American journal of hypertension</s0>
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</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
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<s2>FR</s2>
<s5>07</s5>
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<fC03 i1="03" i2="X" l="ENG"><s0>Omapatrilat</s0>
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<s5>07</s5>
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<fC03 i1="03" i2="X" l="SPA"><s0>Omapatrilat</s0>
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<fC03 i1="04" i2="X" l="FRE"><s0>Chimiothérapie</s0>
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<s5>16</s5>
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<fC03 i1="07" i2="X" l="FRE"><s0>Homme</s0>
<s5>20</s5>
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<s5>20</s5>
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<fC03 i1="07" i2="X" l="SPA"><s0>Hombre</s0>
<s5>20</s5>
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<fC03 i1="08" i2="X" l="FRE"><s0>Antihypertenseur</s0>
<s5>29</s5>
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<fC03 i1="08" i2="X" l="ENG"><s0>Antihypertensive agent</s0>
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<fC03 i1="08" i2="X" l="SPA"><s0>Antihipertensivo</s0>
<s5>29</s5>
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<s5>37</s5>
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<s5>37</s5>
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<fC07 i1="01" i2="X" l="SPA"><s0>Aparato circulatorio patología</s0>
<s5>37</s5>
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<fC07 i1="02" i2="X" l="FRE"><s0>Vaisseau sanguin pathologie</s0>
<s5>38</s5>
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<fC07 i1="02" i2="X" l="ENG"><s0>Vascular disease</s0>
<s5>38</s5>
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<fC07 i1="02" i2="X" l="SPA"><s0>Vaso sanguíneo patología</s0>
<s5>38</s5>
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Design of the Omapatrilat in Persons with Enhanced Risk of atherosclerotic events (OPERA) trial

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

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