Phase 3
N=2,201
Occluded Artery Trial (OAT)
Cardiovascular Diseases · Heart Diseases · Myocardial Infarction · Heart Failure, Congestive · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00004562 ↗Enrolled (actual)
2,201
Serious AEs
20.6%
Results posted
Feb 2013
Primary outcome: Primary: 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) — 230; 219 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Beta adrenergic blockers (Drug); Platelet inhibitors (Drug); PTCA and stents (Procedure); ACE Inhibitors (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
230; 219 | — |
| SECONDARY Number of Participants With Secondary Outcomes (Safety Events) |
150; 153; 77; 65; 75; 61 | — |
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.
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 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 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
Data sourced from ClinicalTrials.gov (NCT00004562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.