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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: | NCT00005493 |
To analyze existing data from the Physicians Health Study (PHS), a randomized primary prevention trial of low-dose aspirin and beta carotene conducted among 22,071 U.S. male physicians, to address questions concerning aspirin and cardiovascular (CV) disease that could not adequately be addressed during the randomized aspirin period.
Condition |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Cerebrovascular Accident |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | April 1998 |
Estimated Study Completion Date: | March 2001 |
DESIGN NARRATIVE:
The aspirin component of the trial was terminated on January 25, 1988, due to a demonstrated benefit of aspirin on myocardial infarction. At that time, however, the number of strokes and CV deaths experienced by trial participants was inadequate to definitively evaluate these endpoints. The beta carotene component of the trial continued uninterrupted until its scheduled termination in December, 1996. During this period detailed information continued to be collected on post-trial aspirin use through annual questionnaires. As of October, 1995, the number of deaths, including cardiovascular deaths, had increased fourfold from that in the randomized period, and the number of strokes had increased 3.5 times. The investigators used data from both the randomized aspirin period and the observational period following the trial to assess the impact of aspirin use on cardiovascular and total mortality, and the long-term impact of aspirin use on subsequent stroke and MI. The methods included analyses of both randomized aspirin assignment and of time-varying aspirin use, as assessed on the annual questionnaires. Because of the potential for bias, the propensity for aspirin use, particularly during the observational period was taken into account. Analyses included use of proportional hazards models allowing for both time-varying effects of aspirin use and controlling for time-varying confounders, as well as more complex procedures using causal modeling.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5010 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005493 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Central Nervous System Diseases Ischemia Arteriosclerosis Brain Diseases |
Cerebrovascular Disorders Coronary Disease Necrosis Aspirin Brain Ischemia Brain Infarction Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Cerebral Infarction Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Arteriosclerosis Ischemia Brain Diseases |
Cerebrovascular Disorders Coronary Disease Necrosis Pathologic Processes Brain Ischemia Cardiovascular Diseases Brain Infarction Infarction Myocardial Infarction Coronary Artery Disease |