Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)
Accession Number
HLB00620808a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
November 1995 - June 2005
NHLBI Division
DCVS
Date Prepared
October 13, 2008
Last Updated
January 15, 2008
Clinical Trial URLs
https://clinicaltrials.gov/ct2/s...
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pub...
Study Website
N/A
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions No
Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes
Genetic Use Of Specimens Allowed? Yes
Genetic Use Area Of Research Restrictions Yes
Specific Consent Restrictions
Consent restricts use of biospecimens to research related to predictors of coronary heart disease progression.
Objectives
To conduct a trial to test the hypothesis that patients with stable coronary artery disease and normal or slightly reduced left ventricular function derive therapeutic benefit from the addition of ACE inhibitors to modern conventional therapy.
Background
Angiotensin-converting-enzyme (ACE) inhibitors are effective in reducing the risk of heart failure, myocardial infarction, and death from cardiovascular causes in patients with left ventricular systolic dysfunction or heart failure. ACE inhibitors have also been shown to reduce atherosclerotic complications in patients who have vascular disease without heart failure.
Subjects
The trial was a double-blind, placebo-controlled study in which 8290 patients were randomly assigned to receive either trandolapril at a target dose of 4 mg per day (4158 patients) or matching placebo (4132 patients).
Conclusions
In patients with stable coronary heart disease and preserved left ventricular function who are receiving "current standard" therapy and in whom the rate of cardiovascular events is lower than in previous trials of ACE inhibitors in patients with vascular disease, there is no evidence that the addition of an ACE inhibitor provides further benefit in terms of death from cardiovascular causes, myocardial infarction, or coronary revascularization. (NEJM 2004;351:2058-2068)
Additional Details
Placebo: 4,132
Active Drug, Trandolapril: 4,158
|
|
Placebo |
Active drug, trandolapril |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
46-50 |
91 |
2.20 |
94 |
2.26 |
185 |
2.23 |
|
51-55 |
610 |
14.76 |
629 |
15.13 |
1239 |
14.95 |
|
56-60 |
781 |
18.90 |
733 |
17.63 |
1514 |
18.26 |
|
61-65 |
817 |
19.77 |
803 |
19.31 |
1620 |
19.54 |
|
66-70 |
795 |
19.24 |
868 |
20.88 |
1663 |
20.06 |
|
71-75 |
621 |
15.03 |
620 |
14.91 |
1241 |
14.97 |
|
76-80 |
349 |
8.45 |
332 |
7.98 |
681 |
8.21 |
|
>=81 |
68 |
1.65 |
79 |
1.90 |
147 |
1.77 |
|
|
Placebo |
Active drug, trandolapril |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Female |
704 |
17.04 |
790 |
19.00 |
1494 |
18.02 |
|
Male |
3428 |
82.96 |
3368 |
81.00 |
6796 |
81.98 |
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
10/26/2018
10/26/2018
| Plasma | ||
|---|---|---|
| Total number of subjects | Average volume (ml) per subject | |
| Baseline | 3,770 | 2.04 |
| Follow-up Visit 1 | 13 | 3.29 |
| Follow-up Visit 2 | 251 | 3.48 |
| Follow-up Visit 3 | 140 | 3.51 |
| Follow-up Visit 4 | 368 | 3.43 |
| Follow-up Visit 5 | 208 | 3.22 |
| Follow-up Visit 6 | 573 | 3.41 |
| Follow-up Visit 7 | 260 | 3.48 |
| Follow-up Visit 8 | 450 | 3.50 |
| Follow-up Visit 9 | 87 | 3.76 |
| Follow-up Visit 10 | 86 | 3.61 |
| Follow-up Visit 11 | 22 | 3.91 |
| Follow-up Visit 12 | 6 | 3.16 |
| Unknown | 306 | 3.48 |
| Urine | ||
|---|---|---|
| Total number of subjects | Average volume (ml) per subject | |
| Baseline | 3,367 | 11.32 |
| Follow-up Visit 1 | 12 | 14.58 |
| Follow-up Visit 2 | 242 | 14.96 |
| Follow-up Visit 3 | 130 | 14.92 |
| Follow-up Visit 4 | 335 | 14.96 |
| Follow-up Visit 5 | 184 | 14.81 |
| Follow-up Visit 6 | 516 | 14.98 |
| Follow-up Visit 7 | 225 | 15.00 |
| Follow-up Visit 8 | 413 | 14.92 |
| Follow-up Visit 9 | 77 | 14.94 |
| Follow-up Visit 10 | 80 | 14.88 |
| Follow-up Visit 11 | 19 | 15.00 |
| Follow-up Visit 12 | 6 | 15.00 |
| Unknown | 244 | 15.30 |
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Resources Available
Specimens and Study DatasetsMaterials Available
- Plasma
- Serum
- Urine
- More Details
Study Documents
Data Dictionary (PDF - 84.3 KB)- Data Dictionary Ancillary (PDF - 46.4 KB)
- Follow-up Visit (PDF - 120.6 KB)
- List of Publications (PDF - 84.4 KB)
- Pre-Randomization Information (PDF - 107.4 KB)
- Protocol (PDF - 126.4 KB)
- Randomization Visit (PDF - 142.4 KB)
- Screening Form (PDF - 125.0 KB)
- PEACE LADS Readme (PDF - 377.2 KB)
- Ancillary Study Documentation
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