Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

NCT00007657

Last updated date
Study Location
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myocardial Ischemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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Myocardial IschemiaClinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
NCT00007657
  1. Scottsdale, Arizona
  2. No. Little Rock, Arkansas
  3. Los Angeles, California
  4. Sacramento, California
  5. Hartford, Connecticut
  6. Newark, Delaware
  7. Melbourne, Florida
  8. Tampa, Florida
  9. Decatur, Georgia
  10. Chicago, Illinois
  11. Davenport, Iowa
  12. Iowa City, Iowa
  13. Lexington, Kentucky
  14. Baltimore, Maryland
  15. Boston, Massachusetts
  16. Ann Arbor, Michigan
  17. Detroit, Michigan
  18. Rochester, Minnesota
  19. Kansas City, Missouri
  20. St Louis, Missouri
  21. Albuquerque, New Mexico
  22. New York, New York
  23. Rochester, New York
  24. Syracuse, New York
  25. Durham, North Carolina
  26. Cleveland, Ohio
  27. Oklahoma City, Oklahoma
  28. Portland, Oregon
  29. Philadelphia, Pennsylvania
  30. Memphis, Tennessee
  31. Nashville, Tennessee
  32. Houston, Texas
  33. San Antonio, Texas
  34. Seattle, Washington
  35. Calgary, Alberta
  36. Edmonton, Alberta
  37. Vancouver, British Columbia
  38. St. John, New Brunswick
  39. Halifax, Nova Scotia
  40. Hamilton, Ontario
  41. London, Ontario
  42. Mississauga, Ontario
  43. Sudbury, Ontario
  44. Toronto, Ontario
  45. Toronto, Ontario
  46. Toronto, Ontario
  47. Montreal, Quebec
  48. Montreal, Quebec
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Myocardial IschemiaAmlodipine vs Nitrates Study in Patients With Chronic Stable Angina
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  3. Athens,
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  7. Patra,
  8. Rio, Patra,
  9. Thessaloniki,
  10. Thessaloniki,
  11. Voula/Athens,
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ALL GENDERS
18 Years+
years
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Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
Official Title  ICMJE CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Myocardial Ischemia
Intervention  ICMJE
  • Procedure: Intensive medical therapy
  • Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 5, 2006)
3260
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
2546
Actual Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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:

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00007657
Other Study ID Numbers  ICMJE 424
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boden, William - Study Chair, Department of Veterans Affairs
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE
  • 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  ICMJE
Study Chair:William E. BodenVA South Texas Health Care System, San Antonio
PRS Account VA Office of Research and Development
Verification Date June 2009

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