Occluded Artery Trial (OAT) (OAT)

April 3, 2014 updated by: NYU Langone Health

Occluded Artery Trial (OAT) - Randomized Comparative Effectiveness Trial of PCI and Medical Therapy Only Post MI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Optimal Medical Therapy Only (MED)
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification
Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Other Names:
  • beta blockers
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Other Names:
  • Antiplatelet drugs
Drug: ACE Inhibitors
Participants will receive ACE inhibitors.
Other Names:
  • angiotensin-converting-enzyme inhibitor
Experimental: Percutaneous Coronary Intervention (PCI)
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Other Names:
  • beta blockers
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Other Names:
  • Antiplatelet drugs
Drug: ACE Inhibitors
Participants will receive ACE inhibitors.
Other Names:
  • angiotensin-converting-enzyme inhibitor
Procedure: PTCA and stents
Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.
Other Names:
  • Percutaneous Transluminal Coronary Angioplasty
  • and
  • Stent Placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Measured over a maximum 9-year follow-up period - 6 year median
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.
Measured over a maximum 9-year follow-up period - 6 year median

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Secondary Outcomes (Safety Events)
Time Frame: Measured over a maximum 9-year follow-up period - 6 year median
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.
Measured over a maximum 9-year follow-up period - 6 year median

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Judith S. Hochman, M.D., NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 9, 2000

First Submitted That Met QC Criteria

February 9, 2000

First Posted (Estimate)

February 10, 2000

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130
  • U01HL062509-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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