Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
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| ClinicalTrials.gov Identifier: NCT00007657 |
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Recruitment Status :
Completed
First Posted : January 4, 2001
Last Update Posted : June 15, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Ischemia | Procedure: Intensive medical therapy Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3260 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Official Title: | CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation |
| Study Start Date : | December 1998 |
| Actual Study Completion Date : | June 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
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Procedure: Intensive medical therapy Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy |
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Active Comparator: 2
Intensive medical therapy
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Procedure: Intensive medical therapy |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
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
| Study Chair: | William E. Boden | VA South Texas Health Care System, San Antonio |
| Responsible Party: | Boden, William - Study Chair, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007657 |
| Other Study ID Numbers: |
424 |
| First Posted: | January 4, 2001 Key Record Dates |
| Last Update Posted: | June 15, 2009 |
| Last Verified: | June 2009 |
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PCI plus intensive medical therapy |
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Myocardial Ischemia Ischemia Pathologic Processes |
Heart Diseases Cardiovascular Diseases Vascular Diseases |