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Prevention of Events with Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

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 Treatment or Intervention Phase
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
 Drug: angiotensin-converting enzyme inhibitors
Phase III

MedlinePlus related topics:  Circulatory Disorders;   Coronary Disease;   Heart Attack;   Heart Diseases;   Heart Diseases--Prevention

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control

Further Study Details: 

Study start: November 1995;  Study completion: June 2005

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.

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


Study chairs or principal investigators

Sarah Fowler,  George Washington University Biostatistics Center   

More Information

http://www.bsc.gwu.edu/peace/

Publications

Pfeffer MA, Domanski M, Rosenberg Y, Verter J, Geller N, Albert P, Hsia J, Braunwald E. Prevention of events with angiotensin-converting enzyme inhibition (the PEACE study design). Prevention of Events with Angiotensin-Converting Enzyme Inhibition. Am J Cardiol. 1998 Aug 6;82(3A):25H-30H.

Pfeffer MA, Domanski M, Verter J, Dunlap M, Flaker GC, Gersh B, Hsia J, Goldberg AD, Limacher MC, Maggioni AP, Rosenberg Y, Rouleau JL, Warnica JW, Wasserman AG, Braunwald E. The continuation of the Prevention of Events With Angiotensin-Converting Enzyme Inhibition (PEACE) Trial. Am Heart J. 2001 Sep;142(3):375-7. No abstract available.

Study ID Numbers:  102
Record last reviewed:  August 2004
Record first received:  October 27, 1999
ClinicalTrials.gov Identifier:  NCT00000558
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-10
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