Coronary Artery Revascularization in Diabetes (VA CARDS)

This study has been terminated.
(Lack of participant enrollment)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00326196
First received: May 12, 2006
Last updated: April 7, 2014
Last verified: April 2014

May 12, 2006
April 7, 2014
July 2006
August 2012   (final data collection date for primary outcome 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. [ Time Frame: Date of Death and non-fatal MI ] [ Designated as safety issue: Yes ]
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
The primary outcome measure for this study will be the time to either death or non-fatal myocardial infarction (MI).
Complete list of historical versions of study NCT00326196 on ClinicalTrials.gov Archive Site
Not Provided
  • Secondary outcome measures will include the costs associated with each treatment strategy,
  • patient health status following each type of Revascularization, 3) to develop risk models for
  • predicting procedure-related outcomes in diabetics undergoing revascularization, and to examine
  • angiographic myocardial jeapardy as a predictor of adverse outcomes following
  • revascularization.
Not Provided
Not Provided
 
Coronary Artery Revascularization in Diabetes
CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

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.

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%.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Percutaneous coronary intervention (PCI)
    percutaneous coronary stenting with drug eluding stents
  • Procedure: Coronary artery bypass graft (CABG)
    coronary bypass
  • Active Comparator: PCI
    Percutaneous coronary intervention
    Interventions:
    • Device: Percutaneous coronary intervention (PCI)
    • Procedure: Coronary artery bypass graft (CABG)
  • Active Comparator: CABG
    Coronary artery bypass graft (CABG)
    Intervention: Procedure: Coronary artery bypass graft (CABG)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
198
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00326196
557
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Study Chair: Masoor Kamalesh, MD Richard Roudebush VA Medical Center, Indianapolis
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP