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
  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
Device: Percutaneous coronary intervention (PCI)
Procedure: Coronary artery bypass graft (CABG)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Enrollment: 198
Study Start Date: July 2006
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PCI
Percutaneous coronary intervention
Device: Percutaneous coronary intervention (PCI)
percutaneous coronary stenting with drug eluding stents
Procedure: Coronary artery bypass graft (CABG)
coronary bypass
Active Comparator: CABG
Coronary artery bypass graft (CABG)
Procedure: Coronary artery bypass graft (CABG)
coronary bypass

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326196

  Show 26 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Masoor Kamalesh, MD Richard Roudebush VA Medical Center, Indianapolis
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00326196     History of Changes
Other Study ID Numbers: 557
Study First Received: May 12, 2006
Results First Received: July 1, 2013
Last Updated: April 7, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
CABG
Coronary Disease
Diabetes
PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014