Coronary Artery Revascularization in Diabetes

Coronary Artery Disease Clinical Trial

— VA CARDS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00326196
• Other study ID #: 557
• Status: Terminated
• Phase: Phase 4
• First received: May 12, 2006
• Last updated: April 7, 2014
• Start date: July 2006
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 198
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous coronary intervention (PCI)
percutaneous coronary stenting with drug eluding stents

Procedure:
• Coronary artery bypass graft (CABG)
coronary bypass

Locations

Country	Name	City	State
United States	VA Medical Center, Asheville	Asheville	North Carolina
United States	VA Medical Center, Birmingham	Birmingham	Alabama
United States	VA Boston Healthcare System, Brockton Campus	Brockton	Massachusetts
United States	Ralph H Johnson VA Medical Center, Charleston	Charleston	South Carolina
United States	VA Medical Center, Cleveland	Cleveland	Ohio
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	VA Eastern Colorado Health Care System, Denver	Denver	Colorado
United States	VA Medical Center, Durham	Durham	North Carolina
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	VA Medical Center, Memphis	Memphis	Tennessee
United States	VA Medical Center, Miami	Miami	Florida
United States	Zablocki VA Medical Center, Milwaukee	Milwaukee	Wisconsin
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	New York Harbor HCS	New York	New York
United States	VA Medical Center, Oklahoma City	Oklahoma City	Oklahoma
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	VA South Texas Health Care System, San Antonio	San Antonio	Texas
United States	VA San Diego Healthcare System, San Diego	San Diego	California
United States	VA Medical Center, San Francisco	San Francisco	California
United States	VA Puget Sound Health Care System, Seattle	Seattle	Washington
United States	VA Greater Los Angeles HCS, Sepulveda	Sepulveda	California
United States	James A. Haley Veterans Hospital, Tampa	Tampa	Florida
United States	Southern Arizona VA Health Care System, Tucson	Tucson	Arizona
United States	VA Medical Center, DC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Card — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.	Date of Death and non-fatal MI	Yes