Compliance in the Physicians' Health Study

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005404
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: May 2000

May 25, 2000
June 23, 2005
February 1991
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Complete list of historical versions of study NCT00005404 on ClinicalTrials.gov Archive Site
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Compliance in the Physicians' Health Study
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To evaluate the relationships of compliance in taking aspirin or aspirin placebo with the risk of major cardiovascular endpoints, using data collected in the Physicians' Health Study.

BACKGROUND:

The Physicians' Health Study was a randomized, double-blind placebo-controlled primary prevention trial designed to test whether 325 mg aspirin every other day reduced risks of cardiovascular disease and whether 50 mg beta-carotene on alternate days decreased cancer incidence among 22,071 male U.S. physicians, aged 40-84 years in 1982. Compliance with study pills, the use of non-study aspirin and platelet active drugs, specific side effects of aspirin, the incidence of conditions indicating aspirin use, and study outcomes were assessed at six month intervals during the first year and annually thereafter. The blinded aspirin component of the trial was terminated early and participants were unblinded on January 25, 1988, due to the emergence of a statistically extreme benefit of aspirin on both fatal and nonfatal myocardial infarction, as well as the extraordinarily low cardiovascular mortality rates among study participants.

DESIGN NARRATIVE:

Separate dose-response relationships were estimated in the aspirin and in the placebo group to determine whether compliance in the placebo group was associated with lower risk, as had been found in some previous trials. Rates of cardiovascular endpoints in the placebo group relative to the aspirin group were adjusted for time-varying compliance with study tablets, and the use of non-study aspirin and platelet active drugs. In addition, baseline characteristics of the population and longitudinal assessment of side-effects and new conditions suggesting aspirin therapy were used as predictors of compliance in taking study pills separately in the aspirin and placebo groups. Similar longitudinal analyses determined predictors of the use of non-study aspirin and platelet active drugs. The analyses were intended to supplement the already published intent-to-treat analyses. They provided observational evidence concerning dose of aspirin and the risks of major cardiovascular endpoints. Examining modification of the aspirin effect in reducing risk of myocardial infarction according to level of compliance aided in the generalizability of results to less motivated populations. Evaluating determinants of good study compliance should be of benefit to future large scale clinical trials.

Observational
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  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Myocardial Infarction
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Glynn RJ, Buring JE, Manson JE, LaMotte F, Hennekens CH. Adherence to aspirin in the prevention of myocardial infarction. The Physicians' Health Study. Arch Intern Med. 1994 Dec 12-26;154(23):2649-57.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 1993
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005404
4321
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National Heart, Lung, and Blood Institute (NHLBI)
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National Heart, Lung, and Blood Institute (NHLBI)
May 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP