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Aspirin-Myocardial Infarction Study (AMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000491
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : March 25, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Drug: aspirin Phase 3

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : October 1974
Actual Study Completion Date : August 1979

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Aspirin

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women, ages 30 to 69. Had a documented myocardial infarction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000491

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: Allan Barker Salt Lake Clinic Research Foundation
OverallOfficial: David Berkson Unity Health Toronto
OverallOfficial: William Berstein Icahn School of Medicine at Mount Sinai
OverallOfficial: Nemat Borhani University of California, Davis
OverallOfficial: Elmer Cooper Santa Rosa Medical Center
OverallOfficial: Leonard Dreifus Lankenau Hospital
OverallOfficial: Noble Fowler University of Cincinnati
OverallOfficial: Phillip Frost USPHS Hospital
OverallOfficial: Mario Garcia-Palmieri University of Puerto Rico Medical Science Campus
OverallOfficial: Hugh Gilmore University of Miami
OverallOfficial: Sidney Goldstein Henry Ford Hospital
OverallOfficial: Olga Haring Northwestern University
OverallOfficial: J. Hoover University of Washington
OverallOfficial: Richard Hutchinson University of Mississippi Medical Center
OverallOfficial: William Krol University of Maryland at Baltimore
OverallOfficial: Peter Kuo Rutgers Medical School
OverallOfficial: Charles, Laubach Institute for Medical Education and Research
OverallOfficial: Bernard Lewis Palo Alto Medical Research Foundation
OverallOfficial: Jessie Marmorston University of Southern California
OverallOfficial: J. McNamara Pacific Health Research Institute
OverallOfficial: Dayton Miller U.S. Centers for Disease Control and Prevention
OverallOfficial: Thaddeus Prout Greater Baltimore Medical Center
OverallOfficial: David Richardson Virginia Commonwealth University
OverallOfficial: Jorge Rios George Washington University
OverallOfficial: Paul Samuel Long Island Jewish-Hillside Medical Center
OverallOfficial: Stephen Scheidt Weill Medical College of Cornell University
OverallOfficial: Robert Schlant Emory University
OverallOfficial: Henry Schoch University of Michigan
OverallOfficial: James Schoenberger Rush University Medical Center
OverallOfficial: Marvin Segal MOUNT SINAI HOSPITAL
OverallOfficial: Pantel Vokonas Boston Health and Hospitals Department
OverallOfficial: C. Williams Ogden Research Foundation
OverallOfficial: Gary Wilner NorthShore University HealthSystem
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AMIS
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.

Aspirin Myocardial Infarction Research Group: A Study of Aspirin in Patients with Myocardial Infarction. Prostaglandins in Hematology. Spectrum Publications Inc, New York, l977, 36l-370.
Aspirin Myocardial Infarction Research Group: Aspirin Myocardial Infarction Study: Design, Methods and Baseline Results. DHEW Pub. No. (NIH) 80-2l06, l980.
Furberg CD, Friedman LM, MacMahon SW: Women as Participants in Trials of the Primary and Secondary Prevention of Cardiovascular Disease: Part II. Secondary Prevention: The Beta-Blocker Heart Attack Trial and the Aspirin Myocardial Infarction Study, in: Coronary Heart Disease in Women. ED Eaker, B Packard, NK Wenger, TB Carkson, HA Tyroler (Eds). New York, Haymarket Doyma, pp 241-246, 1987.

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ClinicalTrials.gov Identifier: NCT00000491    
Other Study ID Numbers: 10
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: April 2012
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors