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Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007657
First Posted: January 4, 2001
Last Update Posted: June 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
VA Office of Research and Development
  Purpose
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.

Condition Intervention Phase
Myocardial Ischemia Procedure: Intensive medical therapy Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 3260
Study Start Date: December 1998
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: 1
Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Procedure: Intensive medical therapy Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Active Comparator: 2
Intensive medical therapy
Procedure: Intensive medical therapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007657


  Show 48 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
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
Investigators
Study Chair: William E. Boden VA South Texas Health Care System, San Antonio
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boden, William - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007657     History of Changes
Other Study ID Numbers: 424
First Submitted: December 29, 2000
First Posted: January 4, 2001
Last Update Posted: June 15, 2009
Last Verified: June 2009

Keywords provided by VA Office of Research and Development:
PCI plus intensive medical therapy

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases