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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
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 27, 1999
First Posted Date  ICMJE October 28, 1999
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE October 1974
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin-Myocardial Infarction Study (AMIS)
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Myocardial Infarction
  • Myocardial Ischemia
Intervention  ICMJE Drug: aspirin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 1979
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Men and women, ages 30 to 69. Had a documented myocardial infarction.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000491
Other Study ID Numbers  ICMJE 10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Allan Barker Salt Lake Clinic Research Foundation
Investigator: David Berkson St. Joseph Hospital Health Center
Investigator: William Berstein Icahn School of Medicine at Mount Sinai
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
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date April 2012

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