Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
angiotensin-converting enzyme inhibitors
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000558
First Posted
October 27, 1999
Last Updated
April 13, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000558
Brief Title
Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 1995 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
angiotensin-converting enzyme inhibitors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Fowler
Organizational Affiliation
George Washington University Biostatistics Center
12. IPD Sharing Statement
Citations:
PubMed Identifier
9719019
Citation
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. doi: 10.1016/s0002-9149(98)00488-3.
Results Reference
background
PubMed Identifier
11526345
Citation
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; PEACE Investigators. The continuation of the Prevention of Events With Angiotensin-Converting Enzyme Inhibition (PEACE) Trial. Am Heart J. 2001 Sep;142(3):375-7. doi: 10.1067/mhj.2001.117603. No abstract available.
Results Reference
background
PubMed Identifier
15531767
Citation
Braunwald E, Domanski MJ, Fowler SE, Geller NL, Gersh BJ, Hsia J, Pfeffer MA, Rice MM, Rosenberg YD, Rouleau JL; PEACE Trial Investigators. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med. 2004 Nov 11;351(20):2058-68. doi: 10.1056/NEJMoa042739. Epub 2004 Nov 7.
Results Reference
background
PubMed Identifier
26336199
Citation
Lachin JM, Bebu I. Application of the Wei-Lachin multivariate one-directional test to multiple event-time outcomes. Clin Trials. 2015 Dec;12(6):627-33. doi: 10.1177/1740774515601027. Epub 2015 Sep 2.
Results Reference
derived
PubMed Identifier
24727254
Citation
Udell JA, Morrow DA, Jarolim P, Sloan S, Hoffman EB, O'Donnell TF, Vora AN, Omland T, Solomon SD, Pfeffer MA, Braunwald E, Sabatine MS. Fibroblast growth factor-23, cardiovascular prognosis, and benefit of angiotensin-converting enzyme inhibition in stable ischemic heart disease. J Am Coll Cardiol. 2014 Jun 10;63(22):2421-8. doi: 10.1016/j.jacc.2014.03.026. Epub 2014 Apr 9.
Results Reference
derived
PubMed Identifier
23414791
Citation
Omland T, Pfeffer MA, Solomon SD, de Lemos JA, Rosjo H, Saltyte Benth J, Maggioni A, Domanski MJ, Rouleau JL, Sabatine MS, Braunwald E; PEACE Investigators. Prognostic value of cardiac troponin I measured with a highly sensitive assay in patients with stable coronary artery disease. J Am Coll Cardiol. 2013 Mar 26;61(12):1240-9. doi: 10.1016/j.jacc.2012.12.026. Epub 2013 Feb 13. Erratum In: J Am Coll Cardiol. 2014 Jan 21;63(2):195-200.
Results Reference
derived
PubMed Identifier
18025537
Citation
Solomon SD, Lin J, Solomon CG, Jablonski KA, Rice MM, Steffes M, Domanski M, Hsia J, Gersh BJ, Arnold JM, Rouleau J, Braunwald E, Pfeffer MA; Prevention of Events With ACE Inhibition (PEACE) Investigators. Influence of albuminuria on cardiovascular risk in patients with stable coronary artery disease. Circulation. 2007 Dec 4;116(23):2687-93. doi: 10.1161/CIRCULATIONAHA.107.723270. Epub 2007 Nov 19.
Results Reference
derived
PubMed Identifier
16801465
Citation
Solomon SD, Rice MM, A Jablonski K, Jose P, Domanski M, Sabatine M, Gersh BJ, Rouleau J, Pfeffer MA, Braunwald E; Prevention of Events with ACE inhibition (PEACE) Investigators. Renal function and effectiveness of angiotensin-converting enzyme inhibitor therapy in patients with chronic stable coronary disease in the Prevention of Events with ACE inhibition (PEACE) trial. Circulation. 2006 Jul 4;114(1):26-31. doi: 10.1161/CIRCULATIONAHA.105.592733. Epub 2006 Jun 26.
Results Reference
derived
Links:
URL
http://www.bsc.gwu.edu/peace/
Description
Related Info
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/peace/
Available IPD/Information Identifier
PEACE
Available IPD/Information Comments
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.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/peace/
Available IPD/Information Type
Study Forms
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/peace/
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Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)
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