Aspirin-Myocardial Infarction Study (AMIS)

March 24, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To determine whether the daily administration of 1 gm of aspirin to individuals with a documented myocardial infarction would result in a significant reduction in mortality over a three year period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

It had been postulated that thrombosis plays a major role in the late stages of coronary artery occlusion. Platelet aggregation is a large component in the formation of arterial thrombi. Theoretically, an agent which prevents the aggregation of platelets would be of value in people with coronary artery disease. Aspirin, in small doses, inhibits platelet aggregation for prolonged periods of time, and therefore might be expected to prevent or retard the occlusion of coronary arteries. This would be reflected in a decrease in the incidence of myocardial infarction and a decrease in mortality due to coronary artery disease.

Several studies had given preliminary evidence that regular administration of aspirin may be of benefit to patients with known coronary artery disease. A National Heart and Lung Institute-sponsored study, the Coronary Drug Project, ran a pilot trial of aspirin and placebo in men with previous myocardial infarctions. Preliminary results from this trial demonstrated its feasibility and led NHLBI to sponsor a more definitive controlled study of the benefit of aspirin in the secondary prevention of coronary heart disease.

An Institute Planning Committee met four times between October 1974 and April 1975 and developed a protocol, manual of operations, and data collection forms. Recruitment of patients began in June 1975, with the first patient randomized on July 2, 1975. Patients who were randomized had been seen at the AMIS Clinical Center for two initial visits and one baseline visit and were free of any reasons for exclusion, such as the current use of anticoagulants and a history of adverse reactions to aspirin. Patients took acetaminophen at times when they would normally take aspirin.

Follow-up was for a minimum of 3 years, with each patient seen at 4-month intervals and monitored for side effects and various nonfatal events, including cardiovascular problems. The primary endpoint was mortality. Annually, a detailed history was obtained and a complete physical examination performed. The study involved 30 clinical centers, a coordinating center, and a central laboratory.

The study completed patient recruitment in the scheduled one year period. A total of 4,524 post-MI patients were enrolled by the 30 clinical centers. Three-year minimum patient follow-up ended in August 1979.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Eligible patients were assigned to a treatment group receiving 1 gm of aspirin daily (the equivalent of three standard aspirin tablets) or to a control group receiving a placebo.

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

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women, ages 30 to 69. Had a documented myocardial infarction.

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Allan Barker, Salt Lake Clinic Research Foundation
  • David Berkson, Unity Health Toronto
  • William Berstein, Icahn School of Medicine at Mount Sinai
  • Nemat Borhani, University of California, Davis
  • Elmer Cooper, Santa Rosa Medical Center
  • Leonard Dreifus, Lankenau Hospital
  • Noble Fowler, University of Cincinnati
  • Phillip Frost, USPHS Hospital
  • Mario Garcia-Palmieri, University of Puerto Rico Medical Science Campus
  • Hugh Gilmore, University of Miami
  • Sidney Goldstein, Henry Ford Hospital
  • Olga Haring, Northwestern University
  • J. Hoover, University of Washington
  • Richard Hutchinson, University of Mississippi Medical Center
  • William Krol, University of Maryland at Baltimore
  • Peter Kuo, Rutgers Medical School
  • Charles, Laubach, Institute for Medical Education and Research
  • Bernard Lewis, Palo Alto Medical Research Foundation
  • Jessie Marmorston, University of Southern California
  • J. McNamara, Pacific Health Research Institute
  • Dayton Miller, U.S. Centers for Disease Control and Prevention
  • Thaddeus Prout, Greater Baltimore Medical Center
  • David Richardson, Virginia Commonwealth University
  • Jorge Rios, George Washington University
  • Paul Samuel, Long Island Jewish-Hillside Medical Center
  • Stephen Scheidt, Weill Medical College of Cornell University
  • Robert Schlant, Emory University
  • Henry Schoch, University of Michigan
  • James Schoenberger, Rush University Medical Center
  • Marvin Segal, Mount Sinai Hospital
  • Pantel Vokonas, Boston Health and Hospitals Department
  • C. Williams, Ogden Research Foundation
  • Gary Wilner, Northshore University Healthsystem

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

October 1, 1974

Study Completion (Actual)

August 1, 1979

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 (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: AMIS
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

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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