Clinical trial NCT00007657: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
Official title: CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Ischemia
Keywords: PCI plus intensive medical therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Medical Research Council of Canada
name: Merck Sharp & Dohme LLC
name: Pfizer
name: GE Healthcare
name: Bristol-Myers Squibb
name: Astellas Pharma Inc
name: AstraZeneca
name: Sanofi
name: Datascope Corp.
name: First Horizon
name: Kos
name: Key Pharmaceuticals
name: Integrated Therapeutics Group
name: Hoest-Marion-Roussel
First posted: 2001-01-04
Enrollment: 3260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: No. Little Rock
country: United States
facility: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
state: Arkansas
city: Los Angeles
country: United States
facility: Southern CA Kaiser Permanente Medical Group
state: California
city: Sacramento
country: United States
facility: VA Northern California HCS
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Systems-Newark, DE
state: Delaware
city: Melbourne
country: United States
facility: MIMA Century Research Associates - Melbourne, FL
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital, Tampa
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VAMC (WestSide Division)
state: Illinois
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Iowa City
country: United States
facility: VA Medical Center, Iowa City
state: Iowa
city: Lexington
country: United States
facility: VA Medical Center, Lexington
state: Kentucky
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester - Rochester, MN
state: Minnesota
city: Kansas City
country: United States
facility: VA Medical Center, Kansas City MO
state: Missouri
city: St Louis
country: United States
facility: VA Medical Center, St Louis
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque
state: New Mexico
city: New York
country: United States
facility: New York Harbor HCS
state: New York
city: Rochester
country: United States
facility: University of Rochester Strong Memorial Hospital
state: New York
city: Syracuse
country: United States
facility: VA Medical Center, Syracuse
state: New York
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Oklahoma City
country: United States
facility: VA Medical Center, Oklahoma City
state: Oklahoma
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: VA Medical Center, Memphis
state: Tennessee
city: Nashville
country: United States
facility: VA Medical Center
state: Tennessee
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: San Antonio
country: United States
facility: VA South Texas Health Care System, San Antonio
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
city: Calgary
country: Canada
facility: Foothills Hospital - Calgary, Alberta - Can
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: St Paul's Hospital, Vancouver - British Columbia
state: British Columbia
city: St. John
country: Canada
facility: St. John Regional Hospital Facility
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital - Hamilton, Ont - Can
state: Ontario
city: London
country: Canada
facility: London Health Sciences Ctr - London, Ont - Can
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Care
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Regional Hospital - Sudbury, Ontario
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook HSC - Toronto, Ontario
state: Ontario
city: Toronto
country: Canada
facility: St. Michael'S Hospital, Toronto, Ontario - Can
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute - Montreal, Quebec - Can
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
affiliation: VA South Texas Health Care System, San Antonio
name: William E. Boden
role: STUDY_CHAIR
References:
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