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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia | Drug: aspirin | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Study Start Date : | October 1974 |
| Actual Study Completion Date : | August 1979 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 69 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000491
| OverallOfficial: | Allan Barker | Salt Lake Clinic Research Foundation | |
| OverallOfficial: | David Berkson | Unity Health Toronto | |
| OverallOfficial: | William Berstein | Icahn School of Medicine at Mount Sinai | |
| OverallOfficial: | Nemat Borhani | University of California, Davis | |
| OverallOfficial: | Elmer Cooper | Santa Rosa Medical Center | |
| OverallOfficial: | Leonard Dreifus | Lankenau Hospital | |
| OverallOfficial: | Noble Fowler | University of Cincinnati | |
| OverallOfficial: | Phillip Frost | USPHS Hospital | |
| OverallOfficial: | Mario Garcia-Palmieri | University of Puerto Rico Medical Science Campus | |
| OverallOfficial: | Hugh Gilmore | University of Miami | |
| OverallOfficial: | Sidney Goldstein | Henry Ford Hospital | |
| OverallOfficial: | Olga Haring | Northwestern University | |
| OverallOfficial: | J. Hoover | University of Washington | |
| OverallOfficial: | Richard Hutchinson | University of Mississippi Medical Center | |
| OverallOfficial: | William Krol | University of Maryland at Baltimore | |
| OverallOfficial: | Peter Kuo | Rutgers Medical School | |
| OverallOfficial: | Charles, Laubach | Institute for Medical Education and Research | |
| OverallOfficial: | Bernard Lewis | Palo Alto Medical Research Foundation | |
| OverallOfficial: | Jessie Marmorston | University of Southern California | |
| OverallOfficial: | J. McNamara | Pacific Health Research Institute | |
| OverallOfficial: | Dayton Miller | U.S. Centers for Disease Control and Prevention | |
| OverallOfficial: | Thaddeus Prout | Greater Baltimore Medical Center | |
| OverallOfficial: | David Richardson | Virginia Commonwealth University | |
| OverallOfficial: | Jorge Rios | George Washington University | |
| OverallOfficial: | Paul Samuel | Long Island Jewish-Hillside Medical Center | |
| OverallOfficial: | Stephen Scheidt | Weill Medical College of Cornell University | |
| OverallOfficial: | Robert Schlant | Emory University | |
| OverallOfficial: | Henry Schoch | University of Michigan | |
| OverallOfficial: | James Schoenberger | Rush University Medical Center | |
| OverallOfficial: | Marvin Segal | MOUNT SINAI HOSPITAL | |
| OverallOfficial: | Pantel Vokonas | Boston Health and Hospitals Department | |
| OverallOfficial: | C. Williams | Ogden Research Foundation | |
| OverallOfficial: | Gary Wilner | NorthShore University HealthSystem |
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.
Publications:
| ClinicalTrials.gov Identifier: | NCT00000491 |
| Other Study ID Numbers: |
10 |
| First Posted: | October 28, 1999 Key Record Dates |
| Last Update Posted: | March 25, 2016 |
| Last Verified: | April 2012 |
|
Cardiovascular Diseases Myocardial Infarction Heart Diseases Coronary Disease Myocardial Ischemia Infarction Ischemia Pathologic Processes Necrosis Vascular Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |