Design of the Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial.
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 (> or = 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.
Kostis
John B
JB
University of Medicine and Dentistry of New Jersey--Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA. kostis@umdnj.edu
Cobbe
Stuart
S
Johnston
Colin
C
Ford
Ian
I
Murphy
Michael
M
Weber
Michael A
MA
Black
Henry R
HR
Plouin
Pierre Francois
PF
Levy
Daniel
D
Mancia
Guiseppe
G
Larochelle
Pierre
P
Kolloch
Rainer E
RE
Alderman
Michael
M
Ruilope
Luis Miguel
LM
Dahlöf
Björn
B
Flack
John M
JM
Wolf
Robert
R
D001161:Arteriosclerosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011480:Protease Inhibitors / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D012107:Research Design; D012307:Risk Factors; D013841:Thiazepines / Q000627:therapeutic use*
D010919:Placebos; D011480:Protease Inhibitors; D011725:Pyridines; D013841:Thiazepines; C106266:omapatrilat