CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,201 enrolled
Drug / intervention
Beta adrenergic blockers +3 moredrug
Likely dose
Beta-adrenergic blockers, platelet inhibitors (aspirin/clopidogrel), ACE inhibitors (standard post-MI medical therapy); experimental arm: percutaneous coronary intervention with PTCA and coronary stentsAI-extracted
Key inclusion· 4
  • ✓Recent myocardial infarction occurring 3-28 days prior to enrollment (Day 1 is calendar day of MI symptom onset)
  • ✓MI confirmed by at least 2 of 3 criteria: ischemic symptoms ≥30 minutes, elevated cardiac serum markers (CK ≥2x ULN with elevated CK-MB, or troponin T/I ≥2x ULN), or EKG changes (new Q-waves ≥0.03 sec in ≥2 related leads, ST-T changes, LBBB, R-wave loss ≥50%, or T-wave inversions ≥3 mm)
  • ✓TIMI flow 0 or 1 (complete or near-complete occlusion) in the infarct-related artery
  • ✓Meets high-risk criteria: ejection fraction <50% OR proximal LAD occlusion (proximal to second major diagonal), large RCA occlusion, or large circumflex with obtuse marginal/inferior wall involvement
Key exclusion· 14
  • ✕Age <18 years
  • ✕Clinical indication for revascularization: rest or low-threshold angina post-MI; severe inducible ischemia (ST depression ≥2 mm, inability to complete stage 1 exercise, or multiple-territory perfusion defects); left main ≥50% stenosis; or triple-vessel disease
  • ✕Serious comorbidity (cancer, pulmonary disease) limiting 3-year survival
  • ✕Severe renal disease: serum creatinine >3.0 mg/dL (increased contrast risk)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00004562
NCT00004562Phase 3Completed
CompareCT.gov

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

NYU Langone Health·interventional·Posted Feb 10, 2000·Updated Apr 21, 2014

In Brief

A Phase 3 clinical trial evaluating Beta adrenergic blockers, Platelet inhibitors, and 2 other interventions for Cardiovascular Diseases and 4 related conditions. Completed, enrolled 2,201 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Heart Diseases, Myocardial Infarction, Heart Failure, Congestive, Heart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2000
Enrollment StartSep 1, 1999
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 26.4 years ago

Interventions

Beta adrenergic blockersdrug

Participants will receive beta adrenergic blockers.

Platelet inhibitorsdrug

Participants will receive platelet inhibitors.

PTCA and stentsprocedure

Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.

ACE Inhibitorsdrug

Participants will receive ACE inhibitors.