Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)
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| ClinicalTrials.gov Identifier: NCT00000558 |
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Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : April 15, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia | Drug: angiotensin-converting enzyme inhibitors | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Study Start Date : | November 1995 |
| Actual Primary Completion Date : | June 2005 |
| Actual Study Completion Date : | June 2005 |
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| Ages Eligible for Study: | 50 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000558
| OverallOfficial: | Sarah Fowler | George Washington University Biostatistics Center |
Study Data/Documents: Individual Participant Data Set
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00000558 |
| Other Study ID Numbers: |
102 |
| First Posted: | October 28, 1999 Key Record Dates |
| Last Update Posted: | April 15, 2016 |
| Last Verified: | January 2008 |
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Cardiovascular Diseases Myocardial Infarction Heart Diseases Coronary Disease Myocardial Ischemia Infarction Ischemia |
Pathologic Processes Necrosis Vascular Diseases Enzyme Inhibitors Angiotensin-Converting Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protease Inhibitors |