Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004562
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2000-02-09
Brief Title:
Occluded Artery Trial OAT
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Occluded Artery Trial OAT - Randomized Comparative Effectiveness Trial of PCI and Medical Therapy Only Post MI
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OAT
Brief Summary:
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 an average 29-year follow-up with extended follow up for an average of six years Long term follow-up of patients were completed in March 2010 Final collection of all regulatory documentation was completed June 2011
Detailed Description:
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 217 clinical sites in the United States Canada and Internationally were randomly allocated to two treatment arms over five 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
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 217 clinical sites in the United States Canada and Internationally were randomly allocated to two treatment arms over five 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL062509-01A1 | NIH | None | httpsreporternihgovquickSearchU01HL062509-01A1 |