To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications...
Date First Received: October 27, 1999
Last Updated: June 23, 2005
Verified by: National Heart, Lung, and Blood Institute (NHLBI), January 2001
Clinical Trial Phase: Phase 3 | Start Date: December 1979
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Detailed Clinical Trial Description
BACKGROUND:
Coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world. Although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction, especially in those patients who enter the hospital early, its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital. When the trial was initiated in 1979, new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy. This prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced. Early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy.
DESIGN NARRATIVE:
Randomized, double-blind. The patients in the experimental group were treated with dipyridamole and aspirin for five years. Patients in the control group received a lactose placebo. The primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease. Secondary endpoints included total mortality, cardiac mortality, mortality due to myocardial infarction, and incidence of new myocardial infarction. Recruitment ended in December 1982.
Intervention(s) in this Clinical Trial
- Drug: aspirin
- Drug: dipyridamole
Criteria for Participation in this Clinical Trial
- Patients aged 65 or less. Angiographically identified coronary heart disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Related Publications
References
[No authors listed] Does the new angiotensin converting enzyme inhibitor cilazapril prevent restenosis after percutaneous transluminal coronary angioplasty? Results of the MERCATOR study: a multicenter, randomized, double-blind placebo-controlled trial. Multicenter European Research Trial with Cilazapril after Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group. Circulation. 1992 Jul;86(1):100-10.
Additional Information
Information obtained from ClinicalTrials.gov on October 15, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000496
Study ID Number: 15
ClinicalTrials.gov Identifier: NCT00000496
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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