Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007657
Status:
COMPLETED
Last Update Posted:
2009-06-15
First Post:
2000-12-29
Brief Title:
Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 164 and 21 respectively which yields an absolute difference of 46 or relative difference of 22 With a minimum duration of follow-up of 2 12 years a maximum of 7 years using a two-sided test of significance at the 005 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 2270 will be needed to test the hypothesis with 85 power Fifteen VA 19 US non-VA and 16 Canadian sites enrolled in the study The planned study duration was 7 years with 4 12 years of patient intake and 2 12 - 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 2270 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 2287 patients enrolled
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 164 and 21 respectively which yields an absolute difference of 46 or relative difference of 22 With a minimum duration of follow-up of 2 12 years a maximum of 7 years using a two-sided test of significance at the 005 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 2270 will be needed to test the hypothesis with 85 power Fifteen VA 19 US non-VA and 16 Canadian sites enrolled in the study The planned study duration was 7 years with 4 12 years of patient intake and 2 12 - 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 2270 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 2287 patients enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None