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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000558 |
To determine whether the addition of angiotensin converting enzyme (ACE) inhibitor to standard therapy in patients with known coronary artery disease and preserved left ventricular function will prevent cardiovascular mortality and reduce the risk of myocardial infarction.
Condition | Intervention | Phase |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia |
Drug: angiotensin-converting enzyme inhibitors |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Study Start Date: | November 1995 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
BACKGROUND:
Individuals with coronary artery disease are at heightened risk for major cardiovascular events. With current advances, a larger segment of our population is manifesting coronary artery disease at a more advanced age. The majority of these individuals have preserved left ventricular function. Prior studies with converting enzyme inhibitor (CEI) therapy in patients with depressed ejection fraction have demonstrated that their long-term administration leads to improved survival and reduced risk of myocardial infarction over and above conventional therapy. There is sufficient rationale and experience to indicate that these benefits will apply to the larger group of individuals with coronary artery disease and preserved left ventricular function and therefore have even broader public health implications. A definitive trial is needed to assess the capacity of CEI therapy to prevent mortality and reduce the risk of myocardial infarction in patients with coronary disease and preserved left ventricular function.
The initiative was proposed by the former Clinical Trials Branch staff and given concept clearance at the May 1994 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in October 1994.
DESIGN NARRATIVE:
A multicenter, randomized clinical trial. There are approximately 180 centers in the United States, Canada, Puerto Rico, and Italy. Patients are randomly assigned to treatment groups in which the addition of the angiotensin-converting enzyme (ACE) inhibitor trandolapril is compared to standard therapy. The primary endpoint includes a reduction in the incidence of cardiovascular death, nonfatal myocardial infarction, or the need for coronary revascularization (PTCA or CABG) in coronary artery disease patients with left ventricular ejection fraction of 40 percent or more. Secondary endpoints include the incidence of hospitalization for the management of either unstable angina, congestive heart failure, stroke, or cardiac arrhythmia.
Recruitment started in November 1996 and ended in June 2000 with a minimum follow-up of five years.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women patients at least 50 years of age with coronary heart disease documented by angiography and a left ventricular ejection fraction of 40 percent or more.
Study ID Numbers: | 102 |
Study First Received: | October 27, 1999 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00000558 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis Protease Inhibitors |
Coronary Disease Necrosis Angiotensin-Converting Enzyme Inhibitors Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Vascular Diseases Enzyme Inhibitors Ischemia Arteriosclerosis Pharmacologic Actions |
Protease Inhibitors Coronary Disease Necrosis Pathologic Processes Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease |