Coronary Artery Revascularization in Diabetes

NCT ID: NCT00326196

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-08-31

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%.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI

Percutaneous coronary intervention

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention (PCI)

Intervention Type: DEVICE

percutaneous coronary stenting with drug eluding stents

Coronary artery bypass graft (CABG)

Intervention Type: PROCEDURE

coronary bypass

CABG

Coronary artery bypass graft (CABG)

Group Type: ACTIVE_COMPARATOR

Coronary artery bypass graft (CABG)

Intervention Type: PROCEDURE

coronary bypass

Interventions

Percutaneous coronary intervention (PCI)

percutaneous coronary stenting with drug eluding stents

Intervention Type: DEVICE

Coronary artery bypass graft (CABG)

coronary bypass

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masoor Kamalesh, MD

Role: STUDY_CHAIR

Richard Roudebush VA Medical Center, Indianapolis

Locations

VA Medical Center, Birmingham

Birmingham, Alabama, United States

Southern Arizona VA Health Care System, Tucson

Tucson, Arizona, United States

VA Palo Alto Health Care System

Palo Alto, California, 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 Greater Los Angeles HCS, Sepulveda

Sepulveda, California, United States

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, United States

VA Medical Center, DC

Washington D.C., District of Columbia, United States

VA Medical Center, Miami

Miami, Florida, United States

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, United States

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, United States

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, United States

VA Medical Center, Minneapolis

Minneapolis, Minnesota, United States

New York Harbor HCS

New York, New York, United States

VA Medical Center, Asheville

Asheville, North Carolina, United States

VA Medical Center, Durham

Durham, North Carolina, United States

VA Medical Center, Cleveland

Cleveland, Ohio, United States

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, United States

Ralph H Johnson VA Medical Center, Charleston

Charleston, South Carolina, United States

VA Medical Center, Memphis

Memphis, Tennessee, United States

VA North Texas Health Care System, Dallas

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, United States

VA South Texas Health Care System, San Antonio

San Antonio, Texas, United States

VA Puget Sound Health Care System, Seattle

Seattle, Washington, United States

Zablocki VA Medical Center, Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23428214 (View on PubMed)

Other Identifiers

557

Identifier Type: -

Identifier Source: org_study_id