NCT00326196

Coronary Artery Revascularization in Diabetes

CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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%.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention (PCI)	percutaneous coronary stenting with drug eluding stents
PROCEDURE	Coronary artery bypass graft (CABG)	coronary bypass

Timeline

• Start date: 2006-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2006-05-16
• Last updated: 2014-04-25
• Results posted: 2014-02-06

Locations

26 sites across 1 country: United States