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Occluded Artery Trial (OAT) (OAT)

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ClinicalTrials.gov Identifier: NCT00004562
Recruitment Status : Completed
First Posted : February 10, 2000
Results First Posted : February 11, 2013
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Heart Failure, Congestive
Heart Failure
Interventions Drug: Beta adrenergic blockers
Drug: Platelet inhibitors
Procedure: PTCA and stents
Drug: ACE Inhibitors
Enrollment 2201
Recruitment Details The primary analysis of the trial included 2166 patients who had been enrolled through December 2005 with an average follow-up of 2.9 years. An additional 35 patients were enrolled through June 2006 during an extended period of enrollment in the nuclear viability ancillary study. All 2201 patients are included here.
Pre-assignment Details  
Arm/Group Title Percutaneous Coronary Intervention Group Medical Therapy Group
Hide Arm/Group Description Percutaneous Coronary Intervention with stent placement and optimal medical therapy Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
Period Title: Overall Study
Started 1101 1100
Completed 999 1009
Not Completed 102 91
Reason Not Completed
Lost to Follow-up             102             91
Arm/Group Title Percutaneous Coronary Intervention Group Medical Therapy Group Total
Hide Arm/Group Description Percutaneous Coronary Intervention with stent placement and optimal medical therapy Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting Total of all reporting groups
Overall Number of Baseline Participants 1101 1100 2201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1101 participants 1100 participants 2201 participants
58.6  (10.9) 58.7  (11.1) 58.7  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1101 participants 1100 participants 2201 participants
Female
242
  22.0%
242
  22.0%
484
  22.0%
Male
859
  78.0%
858
  78.0%
1717
  78.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1101 participants 1100 participants 2201 participants
White 888 875 1763
Black or African American 33 36 69
Hispanic 141 136 277
Other 39 53 92
Current cigarette smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1101 participants 1100 participants 2201 participants
Current Cigaratte Smoker 428 431 859
Non-Smoker 664 660 1324
Unknown 9 9 18
Prior History of Characteristics and Risk Factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1101 participants 1100 participants 2201 participants
Angina 240 255 495
Myocardial infarction 129 118 247
Cerebrovascular disease 48 34 82
Peripheral-vessel disease 44 39 83
Heart Failure 27 25 52
PCI 51 54 105
CABG 5 4 9
Diabetes 203 251 454
Diabetes - Insulin Use 63 61 124
Hypertension 528 543 1071
[1]
Measure Description: Some study participants had more than one characteristic/risk factor and may be counted more than once.
Infarct-related artery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1101 participants 1100 participants 2201 participants
Left anterior descending coronary artery 383 410 793
Left circumflex coronary artery 177 158 335
Right coronary artery 541 532 1073
[1]
Measure Description: Angiographic characteristic
Interval between MI and randomization  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 1101 participants 1100 participants 2201 participants
8
(5 to 16)
8
(5 to 17)
8
(5 to 17)
1.Primary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Coronary Intervention Group Medical Therapy Group
Hide Arm/Group Description:
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
Overall Number of Participants Analyzed 1101 1100
Measure Type: Number
Unit of Measure: participants
230 219
2.Secondary Outcome
Title Number of Participants With Secondary Outcomes (Safety Events)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Coronary Intervention Group Medical Therapy Group
Hide Arm/Group Description:
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
Overall Number of Participants Analyzed 1101 1100
Measure Type: Number
Unit of Measure: participants
Death from all causes 150 153
Fatal and nonfatal reinfarction 77 65
Nonfatal reinfarction 75 61
NYHA class IV heart failure (HF) 51 53
Cardiovascular death 77 81
Death or nonfatal reinfarction 212 199
NYHA class III or IV HF 76 74
Death, reinfarction, or NYHA class III or IV HF 249 235
Stroke 29 24
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Percutaneous Coronary Intervention Group Medical Therapy Group
Hide Arm/Group Description Percutaneous Coronary Intervention with stent placement and optimal medical therapy Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
All-Cause Mortality
Percutaneous Coronary Intervention Group Medical Therapy Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Percutaneous Coronary Intervention Group Medical Therapy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   226/1101 (20.53%)      227/1100 (20.64%)    
Cardiac disorders     
Death from all causes   150/1101 (13.62%)  150 153/1100 (13.91%)  153
NYHA class III or IV Heart Failure   76/1101 (6.90%)  76 74/1100 (6.73%)  74
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Percutaneous Coronary Intervention Group Medical Therapy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/1101 (6.81%)      61/1100 (5.55%)    
Cardiac disorders     
Nonfatal reinfarction   75/1101 (6.81%)  75 61/1100 (5.55%)  61
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.
Results Point of Contact
Name/Title: Judith S. Hochman, M.D.
Organization: New York University School of Medicine
Phone: 212-263-6927
Other Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00004562     History of Changes
Other Study ID Numbers: 130
U01HL062509-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2000
First Posted: February 10, 2000
Results First Submitted: May 7, 2010
Results First Posted: February 11, 2013
Last Update Posted: April 21, 2014