Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000500 |
To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Drug: aspirin Drug: carotene |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind |
Study Start Date: | September 1981 |
BACKGROUND:
Thrombosis plays a major role in the late stages of coronary occlusion. Platelet aggregation is a large component in the formation of arterial thrombi. In pharmacologic studies, aspirin has been shown to inhibit platelet aggregation and, therefore, might be expected to prevent coronary occlusion. These effects are apparent in the dose range of l00-l000 mg/day, and may be most evident at l60 milligrams daily. Higher doses seem to be no more effective in either inhibition of platelet agreeability or prolonged bleeding time.
Although an early case-control study by Jick and Miettinen showed a large benefit, most observational studies had shown a cardiovascular benefit of about 20 percent. Conclusive data could only result from a randomized trial with a large sample size.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. Participants were randomized into one of four treatment groups: one 325 milligram aspirin tablet every other day, alternating with one 30 milligram capsule of beta-carotene; one aspirin every other day, alternating with one capsule of beta-carotene placebo; one aspirin placebo tablet every other day, alternating with one capsule of beta-carotene; and one aspirin placebo tablet every other day, alternating with one capsule of beta-carotene placebo. Major endpoints for the cardiovascular component of the study were cardiovascular mortality, total mortality, and coronary events.
Ages Eligible for Study: | 40 Years to 84 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Male physicians, ages 40 to 84. No history of stroke, myocardial infarction, cancer, or renal disease. No contraindications to aspirin or beta-carotene. No current usage of aspirin or Vitamin A tables greater than once per week.
Study ID Numbers: | 19 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000500 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Aspirin Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Carotenoids Coronary Artery Disease |
Pathologic Processes Cardiovascular Diseases |