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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00004562 |
Purpose
The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over a three year follow-up.
| Condition | Intervention | Phase |
|
Cardiovascular Diseases Heart Diseases Myocardial Infarction Heart Failure, Congestive Heart Failure |
Drug: Beta adrenergic blockers Drug: Platelet inhibitors Procedure: PTCA and stents Drug: ACE Inhibitors |
Phase III |
| MedlinePlus related topics: | Heart Attack Heart Diseases Heart Failure |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Occluded Artery Trial (OAT) |
| Enrollment: | 2166 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification
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Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Drug: ACE Inhibitors
Participants will receive ACE inhibitors.
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2: Experimental
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
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Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Procedure: PTCA and stents
Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.
Drug: ACE Inhibitors
Participants will receive ACE inhibitors.
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BACKGROUND:
The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12 - 24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity.
DESIGN NARRATIVE:
Multicenter, randomized, controlled. Patients at approximately 320 clinical sites in the United States and Canada are randomly allocated to two treatment arms over two years. One treatment consists of conventional medical management including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification. The other treatment consists of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. The primary composite endpoint is mortality, recurrent myocardial infarction, and hospitalization for NYHA Class IV congestive heart failure over a three year follow-up. Individual components of the study composite primary endpoint will be compared in the two treatment arms, as will the medical costs of the two treatments and the health-related quality of life. The cost-effectiveness of percutaneous revascularization will be assessed in the study population.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | New York University School of Medicine ( Judith Hochman ) |
| Study ID Numbers: | 130 |
| First Received: | February 9, 2000 |
| Last Updated: | September 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004562 |
| Health Authority: | United States: Federal Government |
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