Observational Aspirin Use and CVD in the Physicians' Health Study

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005493
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

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
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Cerebrovascular Accident

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1998
Estimated Study Completion Date: March 2001
Detailed Description:

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005493

Sponsors and Collaborators
Investigators
Investigator: Nancy Cook Brigham and Women's Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005493     History of Changes
Other Study ID Numbers: 5010
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebral Infarction
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Stroke
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014