Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

Myocardial Ischemia Clinical Trial

Official title:

CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007657
• Other study ID #: 424
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2000
• Last updated: June 12, 2009
• Start date: December 1998
• Est. completion date: June 2006

Study information

• Verified date: June 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3260
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• Intensive medical therapy

• Percutaneous Coronary Intervention (PCI) plus intensive medical therapy

Locations

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

Sponsors (15)

Lead Sponsor	Collaborator
VA Office of Research and Development	Astellas Pharma Inc, AstraZeneca, Bristol-Myers Squibb, Datascope Corp., First Horizon, GE Healthcare, Hoest-Marion-Roussel, Integrated Therapeutics Group, Key Pharmaceuticals, Kos, Medical Research Council of Canada, Merck Sharp & Dohme Corp., Pfizer, Sanofi

Countries where clinical trial is conducted

United States,  Canada,