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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000558
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 15, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 27, 1999
First Posted Date  ICMJE October 28, 1999
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE November 1995
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Myocardial Infarction
  • Myocardial Ischemia
Intervention  ICMJE Drug: angiotensin-converting enzyme inhibitors
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000558
Other Study ID Numbers  ICMJE 102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Sarah Fowler George Washington University Biostatistics Center
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP