Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
- Conditions
- Myocardial Ischemia
- Interventions
- Procedure: Intensive medical therapyProcedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
- Registration Number
- NCT00007657
- Lead Sponsor
- US Department of Veterans Affairs
- Brief Summary
PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI.
- Detailed Description
Primary Hypothesis: The strategy of PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI in patients with documented myocardial ischemia who meet an AHA task force Class I indication for PCI.
Secondary Hypotheses: Resource utilization and QOL comparisons and hospitalization for acute coronary syndromes will be superior in PCI plus medical therapy compared to medical therapy alone.
Primary Outcomes: All cause mortality, nonfatal MI.
Interventions: All patients will be treated with intensive medical therapy. In addition half of them will receive percutaneous coronary intervention (PCI).
Study Abstract: The COURAGE Trial is a large-scale, multicenter, randomized controlled trial comparing medical therapy and PCI plus medical therapy that is powered for "hard" clinical endpoints. Patients eligible for inclusion in COURAGE will comprise all but very high-risk subjects, and will include those with chronic angina pectoris (Canadian Cardiovascular Society \[CCS\] Class I-III), recent uncomplicated MI, and asymptomatic (or "silent") myocardial ischemia. Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery or PCI. We project cumulative 3-year event rates of 16.4% and 21%, respectively, which yields an absolute difference of 4.6% or relative difference of 22%. With a minimum duration of follow-up of 2 1/2 years, a maximum of 7 years, using a two-sided test of significance at the 0.05 level, and assuming a 3% crossover rate then 2% then 1% each for 2 years from meds to PCI, and annual loss to follow-up rate of 1% these event rates indicate that a sample size of 2,270 will be needed to test the hypothesis with 85% power. Fifteen VA, 19 U.S. non-VA, and 16 Canadian sites enrolled in the study. The planned study duration was 7 years, with 4 1/2 years of patient intake and 2 1/2 - 7 years of follow-up. Study operations began in January 1999 and enrollment began in June 1999. The Data and Safety Monitoring Board approved reducing the sample size to 2,270 subjects based on increasing the length of randomization and follow-up and updating the definition of MI to include biomarker positive (troponin) ACS. Enrollment is complete with 2,287 patients enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3260
- Patients eligible for inclusion in COURAGE will comprise all but very high-risk subjects, and will include those with chronic angina pectoris (Canadian Cardiovascular Society [CCS] Class I-III), uncomplicated MI, cooled down ACS, and asymptomatic (or "silent") myocardial ischemia.
- Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery or PCI.
It is important to emphasize that as many types of CAD patients as possible--reflecting the spectrum of patients encountered in contemporary clinical practice--will be enrolled in COURAGE.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Intensive medical therapy Percutaneous Coronary Intervention (PCI) plus intensive medical therapy 1 Percutaneous Coronary Intervention (PCI) plus intensive medical therapy Percutaneous Coronary Intervention (PCI) plus intensive medical therapy 2 Intensive medical therapy Intensive medical therapy
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
VA Medical Center, Memphis
🇺🇸Memphis, Tennessee, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Foothills Hospital - Calgary, Alberta - Can
🇨🇦Calgary, Alberta, Canada
St Paul's Hospital, Vancouver - British Columbia
🇨🇦Vancouver, British Columbia, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Southern CA Kaiser Permanente Medical Group
🇺🇸Los Angeles, California, United States
Atlanta VA Medical and Rehab Center, Decatur
🇺🇸Decatur, Georgia, United States
VA Medical Center, Cleveland
🇺🇸Cleveland, Ohio, United States
Sunnybrook HSC - Toronto, Ontario
🇨🇦Toronto, Ontario, Canada
John D. Dingell VA Medical Center, Detroit
🇺🇸Detroit, Michigan, United States
Mayo Clinic Rochester - Rochester, MN
🇺🇸Rochester, Minnesota, United States
VA Medical Center, Durham
🇺🇸Durham, North Carolina, United States
VA Medical Center
🇺🇸Nashville, Tennessee, United States
VA South Texas Health Care System, San Antonio
🇺🇸San Antonio, Texas, United States
James A. Haley Veterans Hospital, Tampa
🇺🇸Tampa, Florida, United States
VA Medical Center, Kansas City MO
🇺🇸Kansas City, Missouri, United States
VA Medical Center, St Louis
🇺🇸St Louis, Missouri, United States
St. Michael'S Hospital, Toronto, Ontario - Can
🇨🇦Toronto, Ontario, Canada
St. John Regional Hospital Facility
🇨🇦St. John, New Brunswick, Canada
Hamilton General Hospital - Hamilton, Ont - Can
🇨🇦Hamilton, Ontario, Canada
Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can
🇨🇦Halifax, Nova Scotia, Canada
New York Harbor HCS
🇺🇸New York, New York, United States
VA Medical Center, Syracuse
🇺🇸Syracuse, New York, United States
VA Medical Center, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
VA Puget Sound Health Care System, Seattle
🇺🇸Seattle, Washington, United States
VA Medical Center, Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
VA Medical Center, Portland
🇺🇸Portland, Oregon, United States
Michael E. DeBakey VA Medical Center (152)
🇺🇸Houston, Texas, United States
University of Rochester Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Trillium Health Care
🇨🇦Mississauga, Ontario, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute - Montreal, Quebec - Can
🇨🇦Montreal, Quebec, Canada
Sudbury Regional Hospital - Sudbury, Ontario
🇨🇦Sudbury, Ontario, Canada
New Mexico VA Health Care System, Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
🇺🇸No. Little Rock, Arkansas, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Christiana Care Health Systems-Newark, DE
🇺🇸Newark, Delaware, United States
VA Northern California HCS
🇺🇸Sacramento, California, United States
MIMA Century Research Associates - Melbourne, FL
🇺🇸Melbourne, Florida, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Jesse Brown VAMC (WestSide Division)
🇺🇸Chicago, Illinois, United States
VA Medical Center, Iowa City
🇺🇸Iowa City, Iowa, United States
VA Ann Arbor Healthcare System
🇺🇸Ann Arbor, Michigan, United States
VA Maryland Health Care System, Baltimore
🇺🇸Baltimore, Maryland, United States
VA Medical Center, Lexington
🇺🇸Lexington, Kentucky, United States
VA Medical Center, Jamaica Plain Campus
🇺🇸Boston, Massachusetts, United States
London Health Sciences Ctr - London, Ont - Can
🇨🇦London, Ontario, Canada