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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000496 |
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.
Condition | Intervention | Phase |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Drug: aspirin Drug: dipyridamole |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Study Start Date: | December 1979 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients aged 65 or less. Angiographically identified coronary heart disease
Study ID Numbers: | 15 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000496 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Aspirin Myocardial Ischemia Vascular Diseases |
Disease Progression Arteriosclerosis Ischemia Dipyridamole Coronary Artery Disease |
Vasodilator Agents Phosphodiesterase Inhibitors Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |