Clinical trial NCT00000491: Aspirin-Myocardial Infarction Study (AMIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Salt Lake Clinic Research Foundation
name: Allan Barker
affiliation: Unity Health Toronto
name: David Berkson
affiliation: Icahn School of Medicine at Mount Sinai
name: William Berstein
affiliation: University of California, Davis
name: Nemat Borhani
affiliation: Santa Rosa Medical Center
name: Elmer Cooper
affiliation: Lankenau Hospital
name: Leonard Dreifus
affiliation: University of Cincinnati
name: Noble Fowler
affiliation: USPHS Hospital
name: Phillip Frost
affiliation: University of Puerto Rico Medical Science Campus
name: Mario Garcia-Palmieri
affiliation: University of Miami
name: Hugh Gilmore
affiliation: Henry Ford Hospital
name: Sidney Goldstein
affiliation: Northwestern University
name: Olga Haring
affiliation: University of Washington
name: J. Hoover
affiliation: University of Mississippi Medical Center
name: Richard Hutchinson
affiliation: University of Maryland at Baltimore
name: William Krol
affiliation: Rutgers Medical School
name: Peter Kuo
affiliation: Institute for Medical Education and Research
name: Charles, Laubach
affiliation: Palo Alto Medical Research Foundation
name: Bernard Lewis
affiliation: University of Southern California
name: Jessie Marmorston
affiliation: Pacific Health Research Institute
name: J. McNamara
affiliation: U.S. Centers for Disease Control and Prevention
name: Dayton Miller
affiliation: Greater Baltimore Medical Center
name: Thaddeus Prout
affiliation: Virginia Commonwealth University
name: David Richardson
affiliation: George Washington University
name: Jorge Rios
affiliation: Long Island Jewish-Hillside Medical Center
name: Paul Samuel
affiliation: Weill Medical College of Cornell University
name: Stephen Scheidt
affiliation: Emory University
name: Robert Schlant
affiliation: University of Michigan
name: Henry Schoch
affiliation: Rush University Medical Center
name: James Schoenberger
affiliation: MOUNT SINAI HOSPITAL
name: Marvin Segal
affiliation: Boston Health and Hospitals Department
name: Pantel Vokonas
affiliation: Ogden Research Foundation
name: C. Williams
affiliation: Endeavor Health
name: Gary Wilner
References:
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.
citation: An intervention study-the aspirin myocardial infarction study. Lipids. 1977 Jan;12(1):59-63. doi: 10.1007/BF02532973.
citation: A randomized, controlled trial of aspirin in persons recovered from myocardial infarction. JAMA. 1980 Feb 15;243(7):661-9.
citation: Aspirin Myocardial Infarction Research Group: Aspirin Myocardial Infarction Study: Design, Methods and Baseline Results. DHEW Pub. No. (NIH) 80-2l06, l980.
citation: The aspirin myocardial infarction study: final results. The Aspirin Myocardial Infarction Study research group. Circulation. 1980 Dec;62(6 Pt 2):V79-84.
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.
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.
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.
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.
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.
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.
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.
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.