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Occluded Artery Trial (OAT) (OAT)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Beta adrenergic blockers
Platelet inhibitors
PTCA and stents
ACE Inhibitors
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Recent MI (3-28 days) (Day 1 is the calendar day of the MI system onset) MI is defined based on at least 2 of 3 MI criteria confirmed by: 1) ischemic symptoms ≥30 minutes, 2) cardiac serum marker elevation (creatine kinase (CK) ≥2x upper limit of normal and CK-MB elevated above the upper limit of the laboratory normal) or troponin T, or troponin I elevated at least twice the upper limit of normal, 3) EKG: New Q-waves of ≥0.03 sec and/or 1/3 of QRS complex in ≥2 related EKG leads. If cardiac serum markers are elevated (2), any one of the following EKG findings satisfy inclusion criteria; new ST-T changes (ST elevation or depression), new left bundle-branch block (LBBB), loss of R-wave voltage ≥50% in ≥2 related leads or deep T wave inversions ≥3mm in ≥2 leads. TIMI flow 0 or 1 in infarct related artery (IRA) Meets criteria for high risk: EF <50% or site of occlusion is proximal, in left anterior descending (proximal to the second major diagonal branch); large right coronary artery; or circumflex, if supplying large obtuse marginal, and part of inferior wall (i.e., large dominant or co-dominant vessel). Exclusion Criteria: Age <18 y Clinical indication for revascularization defined as follows: rest or low-threshold angina after MI; severe inducible ischemia on low level exercise or pharmacological stress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4 metabolic equivalents without angina, hypotension, or reversible perfusion defects in multiple territories or decreased wall motion thickening in >2 segments on echocardiogram); left main coronary disease (≥50% stenosis); or triple-vessel disease (3 major epicardial coronaries with >70% stenoses) Serious illness such as cancer or pulmonary disease that limits 3-year survival Severe renal disease defined as serum creatinine >3.0 mg/dL that markedly increases risk of radiographic contrast Severe valvular disease History of anaphylaxis to radiographic contrast Infarct artery too small (reference segment diameter <2.5 mm), target segment within or beyond extreme tortuosity (>90° angulation), or otherwise technically a poor candidate for PCI Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographic evidence of chronicity, e.g., presence of bridging collaterals) NYHA classes III-IV CHF; patients may be treated for acute heart failure complicating MI and rescreened Cardiogenic shock or sustained hypotension: systolic BP <90 mm Hg or cardiac index <2.2 L/min per m^2 LV aneurysm in the same location as index MI and present before index MI Inability to cooperate with the protocol Patient refusal or inability to give informed consent Refusal of patient's physician to allow patient to participate Pregnancy Contraindication to anticoagulation during PCI or to routine antiplatelet therapy after stent implantation Qualifying IRA that has been grafted previously; patients with prior CABG may be enrolled if the IRA was not previously grafted Dilated or hypertrophic cardiomyopathy

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Optimal Medical Therapy Only (MED)

Percutaneous Coronary Intervention (PCI)

Arm Description

Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification

Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting

Outcomes

Primary Outcome Measures

Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)
Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.

Secondary Outcome Measures

Number of Participants With Secondary Outcomes (Safety Events)
Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.

Full Information

First Posted
February 9, 2000
Last Updated
April 3, 2014
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004562
Brief Title
Occluded Artery Trial (OAT)
Acronym
OAT
Official Title
Occluded Artery Trial (OAT) - Randomized Comparative Effectiveness Trial of PCI and Medical Therapy Only Post MI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 2.9-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Heart Failure, Congestive, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal Medical Therapy Only (MED)
Arm Type
Active Comparator
Arm Description
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification
Arm Title
Percutaneous Coronary Intervention (PCI)
Arm Type
Experimental
Arm Description
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
Intervention Type
Drug
Intervention Name(s)
Beta adrenergic blockers
Other Intervention Name(s)
beta blockers
Intervention Description
Participants will receive beta adrenergic blockers.
Intervention Type
Drug
Intervention Name(s)
Platelet inhibitors
Other Intervention Name(s)
Antiplatelet drugs
Intervention Description
Participants will receive platelet inhibitors.
Intervention Type
Procedure
Intervention Name(s)
PTCA and stents
Other Intervention Name(s)
Percutaneous Transluminal Coronary Angioplasty, and, Stent Placement
Intervention Description
Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.
Intervention Type
Drug
Intervention Name(s)
ACE Inhibitors
Other Intervention Name(s)
angiotensin-converting-enzyme inhibitor
Intervention Description
Participants will receive ACE inhibitors.
Primary Outcome Measure Information:
Title
Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)
Description
Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.
Time Frame
Measured over a maximum 9-year follow-up period - 6 year median
Secondary Outcome Measure Information:
Title
Number of Participants With Secondary Outcomes (Safety Events)
Description
Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.
Time Frame
Measured over a maximum 9-year follow-up period - 6 year median

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recent MI (3-28 days) (Day 1 is the calendar day of the MI system onset) MI is defined based on at least 2 of 3 MI criteria confirmed by: 1) ischemic symptoms ≥30 minutes, 2) cardiac serum marker elevation (creatine kinase (CK) ≥2x upper limit of normal and CK-MB elevated above the upper limit of the laboratory normal) or troponin T, or troponin I elevated at least twice the upper limit of normal, 3) EKG: New Q-waves of ≥0.03 sec and/or 1/3 of QRS complex in ≥2 related EKG leads. If cardiac serum markers are elevated (2), any one of the following EKG findings satisfy inclusion criteria; new ST-T changes (ST elevation or depression), new left bundle-branch block (LBBB), loss of R-wave voltage ≥50% in ≥2 related leads or deep T wave inversions ≥3mm in ≥2 leads. TIMI flow 0 or 1 in infarct related artery (IRA) Meets criteria for high risk: EF <50% or site of occlusion is proximal, in left anterior descending (proximal to the second major diagonal branch); large right coronary artery; or circumflex, if supplying large obtuse marginal, and part of inferior wall (i.e., large dominant or co-dominant vessel). Exclusion Criteria: Age <18 y Clinical indication for revascularization defined as follows: rest or low-threshold angina after MI; severe inducible ischemia on low level exercise or pharmacological stress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4 metabolic equivalents without angina, hypotension, or reversible perfusion defects in multiple territories or decreased wall motion thickening in >2 segments on echocardiogram); left main coronary disease (≥50% stenosis); or triple-vessel disease (3 major epicardial coronaries with >70% stenoses) Serious illness such as cancer or pulmonary disease that limits 3-year survival Severe renal disease defined as serum creatinine >3.0 mg/dL that markedly increases risk of radiographic contrast Severe valvular disease History of anaphylaxis to radiographic contrast Infarct artery too small (reference segment diameter <2.5 mm), target segment within or beyond extreme tortuosity (>90° angulation), or otherwise technically a poor candidate for PCI Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographic evidence of chronicity, e.g., presence of bridging collaterals) NYHA classes III-IV CHF; patients may be treated for acute heart failure complicating MI and rescreened Cardiogenic shock or sustained hypotension: systolic BP <90 mm Hg or cardiac index <2.2 L/min per m^2 LV aneurysm in the same location as index MI and present before index MI Inability to cooperate with the protocol Patient refusal or inability to give informed consent Refusal of patient's physician to allow patient to participate Pregnancy Contraindication to anticoagulation during PCI or to routine antiplatelet therapy after stent implantation Qualifying IRA that has been grafted previously; patients with prior CABG may be enrolled if the IRA was not previously grafted Dilated or hypertrophic cardiomyopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith S. Hochman, M.D.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16209957
Citation
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Occluded Artery Trial (OAT)

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