Aspirin-Myocardial Infarction Study (AMIS) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 27, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1974

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Aspirin-Myocardial Infarction Study (AMIS)

Official Title ^ICMJE

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind

Condition ^ICMJE

Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia

Intervention ^ICMJE

Drug: aspirin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00000491

Responsible Party

Study ID Numbers ^ICMJE

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

February 2002

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