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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00326196 |
Purpose
This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes. The hypothesis being tested is that a strategy of surgical revascularization is superior to percutaneous intervention in preventing death or myocardial infarction in diabetics with severe ischemic heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: Percutaneous coronary intervention (PCI) Procedure: Coronary artery bypass graft (CABG) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS) |
| Estimated Enrollment: | 790 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Procedure: Percutaneous coronary intervention (PCI)
percutaneous coronary stenting with drug eluding stents
Procedure: Coronary artery bypass graft (CABG)
coronary bypass
|
Diabetic patients (HbA1c greater than 6.0% if treated or greater than 6.9% untreated) with severe ischemic heart disease and clinical indications for coronary revascularization will be screened and, if agreeable, entered into the study. Qualified patients unwilling to participate in the randomized trial will be approached for participation in a Registry that will collect computerized health data. The study consists of a 4-year accrual period. The median follow-up will be 3.7 years with a maximum of six years and a minimum of two years. Six sites will begin recruitment in the first year followed by nine additional sites for the remaining three years. The study is powered to detect a 40% relative difference between the groups in time to death or MI with a two-sided, type I error of 5% and a power of 90%.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with diabetes with severe coronary artery disease
Exclusion Criteria:
Contacts and Locations| Contact: Masoor Kamalesh, MD | (317) 988-2081 | Masoor.Kamalesh@va.gov |
| Contact: Vicki R Williams, RN | (317) 988-2054 | vicki.williams@va.gov |
Show 26 Study Locations| Study Chair: | Masoor Kamalesh, MD | Richard Roudebush VA Medical Center, Indianapolis |
More Information
| Responsible Party: | Department of Veterans Affairs ( Kamalesh, Masoor - Study Chair ) |
| Study ID Numbers: | 557 |
| Study First Received: | May 12, 2006 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00326196 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
CABG Coronary Disease Diabetes PCI |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |