Clinical trial NCT00326196: Coronary Artery Revascularization in Diabetes
Official title: CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: CABG
Coronary Disease
Diabetes
PCI
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-05-16
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%.

Eligibility criteria: Inclusion Criteria:

Patients with diabetes with severe coronary artery disease General Inclusion Criteria

1. Age at least 18 years old
2. Patients with either Type I or Type II diabetes with a documented HbA1c greater than site ULN (If not on diabetic medication must be confirmed by a blood glucose of \>126 mg/dL fasting, or \>200mg/dL non-fasting); OR on diabetic medication with a documented physician diagnosis of diabetes mellitus.
3. No child bearing potential (if female)
4. Patient competent to provide consent

   Exclusion Criteria:

   General Exclusion Criteria
5. Congenital heart disease
6. Coronary bypass surgery within the preceding one year
7. Need for concomitant cardiac surgery
8. AHA Class III decompensated heart failure or AHA Class IV heart failure
9. Undergoing PCI for hemodynamic instability related to acute STEMI
10. History of a hemorrhagic stroke
11. Severe bleeding diathesis
12. History of chronic pancreatitis
13. A severe co-morbid condition that is expected to limit life to less than two years
14. Embolic stroke in the past six months
15. Significant GI bleed within the last one month
16. Lack of adequate surgical conduit
17. Sensitivity to clopidogrel (Plavix)
18. Sensitivity to glycoprotein IIb/IIIa inhibitors
19. Chronic systemic steroid use
20. Participation in another trial with active intervention
21. Patient unable to be adequately followed

Primary outcomes:
measure: The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.
timeFrame: Date of Death and non-fatal MI
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: VA Medical Center, Birmingham
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System, Tucson
state: Arizona
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
city: Sepulveda
country: United States
facility: VA Greater Los Angeles HCS, Sepulveda
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver
state: Colorado
city: Washington
country: United States
facility: VA Medical Center, DC
state: District of Columbia
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital, Tampa
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: Indianapolis
country: United States
facility: Richard Roudebush VA Medical Center, Indianapolis
state: Indiana
city: Brockton
country: United States
facility: VA Boston Healthcare System, Brockton Campus
state: Massachusetts
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: New York
country: United States
facility: New York Harbor HCS
state: New York
city: Asheville
country: United States
facility: VA Medical Center, Asheville
state: North Carolina
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Oklahoma City
country: United States
facility: VA Medical Center, Oklahoma City
state: Oklahoma
city: Charleston
country: United States
facility: Ralph H Johnson VA Medical Center, Charleston
state: South Carolina
city: Memphis
country: United States
facility: VA Medical Center, Memphis
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care System, Dallas
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: San Antonio
country: United States
facility: VA South Texas Health Care System, San Antonio
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
city: Milwaukee
country: United States
facility: Zablocki VA Medical Center, Milwaukee
state: Wisconsin
Study officials:
affiliation: Richard Roudebush VA Medical Center, Indianapolis
name: Masoor Kamalesh, MD
role: STUDY_CHAIR
References:
citation: Kamalesh M, Sharp TG, Tang XC, Shunk K, Ward HB, Walsh J, King S 3rd, Colling C, Moritz T, Stroupe K, Reda D; VA CARDS Investigators. Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes. J Am Coll Cardiol. 2013 Feb 26;61(8):808-16. doi: 10.1016/j.jacc.2012.11.044.