Aspirin-Myocardial Infarction Study (AMIS)
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Men and women, ages 30 to 69. Had a documented myocardial infarction.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000491
First Posted
October 27, 1999
Last Updated
March 24, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000491
Brief Title
Aspirin-Myocardial Infarction Study (AMIS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 1974 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1979 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aspirin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women, ages 30 to 69. Had a documented myocardial infarction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Barker
Organizational Affiliation
Salt Lake Clinic Research Foundation
First Name & Middle Initial & Last Name & Degree
David Berkson
Organizational Affiliation
Unity Health Toronto
First Name & Middle Initial & Last Name & Degree
William Berstein
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
First Name & Middle Initial & Last Name & Degree
Nemat Borhani
Organizational Affiliation
University of California, Davis
First Name & Middle Initial & Last Name & Degree
Elmer Cooper
Organizational Affiliation
Santa Rosa Medical Center
First Name & Middle Initial & Last Name & Degree
Leonard Dreifus
Organizational Affiliation
Lankenau Hospital
First Name & Middle Initial & Last Name & Degree
Noble Fowler
Organizational Affiliation
University of Cincinnati
First Name & Middle Initial & Last Name & Degree
Phillip Frost
Organizational Affiliation
USPHS Hospital
First Name & Middle Initial & Last Name & Degree
Mario Garcia-Palmieri
Organizational Affiliation
University of Puerto Rico Medical Science Campus
First Name & Middle Initial & Last Name & Degree
Hugh Gilmore
Organizational Affiliation
University of Miami
First Name & Middle Initial & Last Name & Degree
Sidney Goldstein
Organizational Affiliation
Henry Ford Hospital
First Name & Middle Initial & Last Name & Degree
Olga Haring
Organizational Affiliation
Northwestern University
First Name & Middle Initial & Last Name & Degree
J. Hoover
Organizational Affiliation
University of Washington
First Name & Middle Initial & Last Name & Degree
Richard Hutchinson
Organizational Affiliation
University of Mississippi Medical Center
First Name & Middle Initial & Last Name & Degree
William Krol
Organizational Affiliation
University of Maryland at Baltimore
First Name & Middle Initial & Last Name & Degree
Peter Kuo
Organizational Affiliation
Rutgers Medical School
First Name & Middle Initial & Last Name & Degree
Charles, Laubach
Organizational Affiliation
Institute for Medical Education and Research
First Name & Middle Initial & Last Name & Degree
Bernard Lewis
Organizational Affiliation
Palo Alto Medical Research Foundation
First Name & Middle Initial & Last Name & Degree
Jessie Marmorston
Organizational Affiliation
University of Southern California
First Name & Middle Initial & Last Name & Degree
J. McNamara
Organizational Affiliation
Pacific Health Research Institute
First Name & Middle Initial & Last Name & Degree
Dayton Miller
Organizational Affiliation
U.S. Centers for Disease Control and Prevention
First Name & Middle Initial & Last Name & Degree
Thaddeus Prout
Organizational Affiliation
Greater Baltimore Medical Center
First Name & Middle Initial & Last Name & Degree
David Richardson
Organizational Affiliation
Virginia Commonwealth University
First Name & Middle Initial & Last Name & Degree
Jorge Rios
Organizational Affiliation
George Washington University
First Name & Middle Initial & Last Name & Degree
Paul Samuel
Organizational Affiliation
Long Island Jewish-Hillside Medical Center
First Name & Middle Initial & Last Name & Degree
Stephen Scheidt
Organizational Affiliation
Weill Medical College of Cornell University
First Name & Middle Initial & Last Name & Degree
Robert Schlant
Organizational Affiliation
Emory University
First Name & Middle Initial & Last Name & Degree
Henry Schoch
Organizational Affiliation
University of Michigan
First Name & Middle Initial & Last Name & Degree
James Schoenberger
Organizational Affiliation
Rush University Medical Center
First Name & Middle Initial & Last Name & Degree
Marvin Segal
Organizational Affiliation
MOUNT SINAI HOSPITAL
First Name & Middle Initial & Last Name & Degree
Pantel Vokonas
Organizational Affiliation
Boston Health and Hospitals Department
First Name & Middle Initial & Last Name & Degree
C. Williams
Organizational Affiliation
Ogden Research Foundation
First Name & Middle Initial & Last Name & Degree
Gary Wilner
Organizational Affiliation
NorthShore University HealthSystem
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
319319
Citation
An intervention study-the aspirin myocardial infarction study. Lipids. 1977 Jan;12(1):59-63. doi: 10.1007/BF02532973.
Results Reference
background
PubMed Identifier
6985998
Citation
A randomized, controlled trial of aspirin in persons recovered from myocardial infarction. JAMA. 1980 Feb 15;243(7):661-9.
Results Reference
background
Citation
Aspirin Myocardial Infarction Research Group: Aspirin Myocardial Infarction Study: Design, Methods and Baseline Results. DHEW Pub. No. (NIH) 80-2l06, l980.
Results Reference
background
PubMed Identifier
7438383
Citation
The aspirin myocardial infarction study: final results. The Aspirin Myocardial Infarction Study research group. Circulation. 1980 Dec;62(6 Pt 2):V79-84.
Results Reference
background
PubMed Identifier
7042113
Citation
Wasserman AG, Bren GB, Ross AM, Richardson DW, Hutchinson RG, Rios JC. Prognostic implications of diagnostic Q waves after myocardial infarction. Circulation. 1982 Jun;65(7):1451-5. doi: 10.1161/01.cir.65.7.1451.
Results Reference
background
PubMed Identifier
6423716
Citation
Goldstein S, Friedman L, Hutchinson R, Canner P, Romhilt D, Schlant R, Sobrino R, Verter J, Wasserman A. Timing, mechanism and clinical setting of witnessed deaths in postmyocardial infarction patients. J Am Coll Cardiol. 1984 May;3(5):1111-7. doi: 10.1016/s0735-1097(84)80167-9.
Results Reference
background
PubMed Identifier
4006489
Citation
Mattson ME, Curb JD, McArdle R. Participation in a clinical trial: the patients' point of view. Control Clin Trials. 1985 Jun;6(2):156-67. doi: 10.1016/0197-2456(85)90121-7.
Results Reference
background
PubMed Identifier
3895879
Citation
Shekelle RB, Gale M, Norusis M. Type A score (Jenkins Activity Survey) and risk of recurrent coronary heart disease in the aspirin myocardial infarction study. Am J Cardiol. 1985 Aug 1;56(4):221-5. doi: 10.1016/0002-9149(85)90838-0.
Results Reference
background
PubMed Identifier
3591604
Citation
Frost PH, Verter J, Miller D. Serum lipids and lipoproteins after myocardial infarction: associations with cardiovascular mortality and experience in the Aspirin Myocardial Infarction Study. Am Heart J. 1987 Jun;113(6):1356-64. doi: 10.1016/0002-8703(87)90648-x.
Results Reference
background
PubMed Identifier
3440392
Citation
Schoenberger JA. Recruitment experience in the Aspirin Myocardial Infarction Study. Control Clin Trials. 1987 Dec;8(4 Suppl):74S-78S. doi: 10.1016/0197-2456(87)90009-2.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
7127995
Citation
Howard J, Whittemore AS, Hoover JJ, Panos M. How blind was the patient blind in AMIS? Clin Pharmacol Ther. 1982 Nov;32(5):543-53. doi: 10.1038/clpt.1982.201.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/amis/
Available IPD/Information Identifier
AMIS
Available IPD/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.
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Aspirin-Myocardial Infarction Study (AMIS)
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