Study Results
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Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1974-10-31
1979-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PREVENTION
DOUBLE
Interventions
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aspirin
Eligibility Criteria
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Inclusion Criteria
30 Years
69 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Principal Investigators
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Allan Barker
Role:
Salt Lake Clinic Research Foundation
David Berkson
Role:
Unity Health Toronto
William Berstein
Role:
Icahn School of Medicine at Mount Sinai
Nemat Borhani
Role:
University of California, Davis
Elmer Cooper
Role:
Santa Rosa Medical Center
Leonard Dreifus
Role:
Lankenau Hospital
Noble Fowler
Role:
University of Cincinnati
Phillip Frost
Role:
USPHS Hospital
Mario Garcia-Palmieri
Role:
University of Puerto Rico Medical Science Campus
Hugh Gilmore
Role:
University of Miami
Sidney Goldstein
Role:
Henry Ford Hospital
Olga Haring
Role:
Northwestern University
J. Hoover
Role:
University of Washington
Richard Hutchinson
Role:
University of Mississippi Medical Center
William Krol
Role:
University of Maryland at Baltimore
Peter Kuo
Role:
Rutgers Medical School
Charles, Laubach
Role:
Institute for Medical Education and Research
Bernard Lewis
Role:
Palo Alto Medical Research Foundation
Jessie Marmorston
Role:
University of Southern California
J. McNamara
Role:
Pacific Health Research Institute
Dayton Miller
Role:
U.S. Centers for Disease Control and Prevention
Thaddeus Prout
Role:
Greater Baltimore Medical Center
David Richardson
Role:
Virginia Commonwealth University
Jorge Rios
Role:
George Washington University
Paul Samuel
Role:
Long Island Jewish-Hillside Medical Center
Stephen Scheidt
Role:
Weill Medical College of Cornell University
Robert Schlant
Role:
Emory University
Henry Schoch
Role:
University of Michigan
James Schoenberger
Role:
Rush University Medical Center
Marvin Segal
Role:
MOUNT SINAI HOSPITAL
Pantel Vokonas
Role:
Boston Health and Hospitals Department
C. Williams
Role:
Ogden Research Foundation
Gary Wilner
Role:
Endeavor Health
References
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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.
An intervention study-the aspirin myocardial infarction study. Lipids. 1977 Jan;12(1):59-63. doi: 10.1007/BF02532973.
A randomized, controlled trial of aspirin in persons recovered from myocardial infarction. JAMA. 1980 Feb 15;243(7):661-9.
Aspirin Myocardial Infarction Research Group: Aspirin Myocardial Infarction Study: Design, Methods and Baseline Results. DHEW Pub. No. (NIH) 80-2l06, l980.
The aspirin myocardial infarction study: final results. The Aspirin Myocardial Infarction Study research group. Circulation. 1980 Dec;62(6 Pt 2):V79-84.
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.
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.
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.
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.
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.
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.
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.
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.
Study Documents
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Document Type: Individual Participant Data Set
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.
View DocumentOther Identifiers
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10
Identifier Type: -
Identifier Source: org_study_id
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