Coronary Artery Revascularization in Diabetes

Stopped early · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00326196

Run by

US Department of Veterans Affairs

People needed

198

Starts

2006-07-01

Expected to finish

2012-08-01

Last updated by the study team

2014-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with diabetes with severe coronary artery disease General Inclusion Criteria
• Age at least 18 years old
• 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.
• No child bearing potential (if female)
• Patient competent to provide consent

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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