Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000558
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
1999-10-27
Brief Title:
Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy PEACE
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: