Physicians' Health Study

January 26, 2021 updated by: John Michael Gaziano, MD, Brigham and Women's Hospital
To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Male physicians, ages 40 to 84. No history of stroke, myocardial infarction, cancer, or renal disease. No contraindications to aspirin or beta-carotene. No current usage of aspirin or Vitamin A tables greater than once per week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1981

Primary Completion (Actual)

December 1, 1995

Study Completion (Actual)

December 1, 1996

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19
  • R01HL034595 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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