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Trial NCT00000491

Resource URI: http://static.linkedct.org/resource/trials/NCT00000491
PropertyValue
linkedct:brief_title Aspirin-Myocardial Infarction Study (AMIS)
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linkedct:criteria Men and women, ages 30 to 69. Had a documented myocardial infarction.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 69 Years
linkedct:eligibility_minimum_age 30 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000491
rdfs:label Trial NCT00000491
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000491
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linkedct:org_study_id 10
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linkedct:overall_status Completed
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foaf:page <http://clinicaltrials.gov/show/NCT00000491>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/1314>
linkedct:reference <http://static.linkedct.org/resource/reference/260>
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linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date October 1974
linkedct:study_design Prevention, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2002