Physicians' Health Study
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ClinicalTrials.gov Identifier: NCT00000500 |
Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : January 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia | Drug: aspirin Drug: carotene | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Prevention |
Study Start Date : | September 1981 |
Actual Primary Completion Date : | December 1995 |
Actual Study Completion Date : | December 1996 |

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Ages Eligible for Study: | 40 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | John Michael Gaziano, MD, Chief, Division of Aging, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00000500 |
Other Study ID Numbers: |
19 R01HL034595 ( U.S. NIH Grant/Contract ) |
First Posted: | October 28, 1999 Key Record Dates |
Last Update Posted: | January 28, 2021 |
Last Verified: | January 2021 |
Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Ischemia Ischemia Pathologic Processes Vascular Diseases Aspirin Carotenoids Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Antioxidants Protective Agents |