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Home > "O" Clinical Trials Conditions > Observational Aspirin Use and CVD in the Physicians' Health Study  Observational Aspirin Use and CVD in the Physicians' Health Study
Observational Aspirin Use and CVD in the Physicians' Health Study
For Condition: Heart Diseases,Cardiovascular Diseases,Cerebrovascular Accident,Myocardial Infarction,Coronary Disease
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NancyCook, , Brigham and Women's Hospital
Additional Information:
Study ID Numbers: 5010;
Study Start Date: April 1998
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005493
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3. Coronary Artery Calcium, Exercise Tests, and CHD Outcome
4. Pooled Analysis of NHANES I/II--Race, Gender, and CHD
5. Effects of Training Intensity on the CHD risk factors in postmenopausal women
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Observational Aspirin Use and CVD in the Physicians' Health Study
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