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Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council of Canada
Merck Sharp & Dohme Corp.
Pfizer
GE Healthcare
Bristol-Myers Squibb
Astellas Pharma Inc
AstraZeneca
Sanofi
Datascope Corp.
First Horizon
Kos
Key Pharmaceuticals
Integrated Therapeutics Group
Hoest-Marion-Roussel
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007657
First received: December 29, 2000
Last updated: June 12, 2009
Last verified: June 2009

December 29, 2000
June 12, 2009
December 1998
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Complete list of historical versions of study NCT00007657 on ClinicalTrials.gov Archive Site
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Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Myocardial Ischemia
  • Procedure: Intensive medical therapy
  • Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
  • Experimental: 1
    Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
    Interventions:
    • Procedure: Intensive medical therapy
    • Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
  • Active Comparator: 2
    Intensive medical therapy
    Intervention: Procedure: Intensive medical therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3260
June 2006
Not Provided

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:

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00007657
424
No
Boden, William - Study Chair, Department of Veterans Affairs
Department of Veterans Affairs
  • Medical Research Council of Canada
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • GE Healthcare
  • Bristol-Myers Squibb
  • Astellas Pharma Inc
  • AstraZeneca
  • Sanofi
  • Datascope Corp.
  • First Horizon
  • Kos
  • Key Pharmaceuticals
  • Integrated Therapeutics Group
  • Hoest-Marion-Roussel
Study Chair: William E. Boden VA South Texas Health Care System, San Antonio
Department of Veterans Affairs
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP