Status:
TERMINATED
Coronary Artery Revascularization in Diabetes
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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, i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00326196
Start Date
July 1 2006
End Date
August 1 2012
Last Update
April 25 2014
Active Locations (26)
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1
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
2
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
3
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
4
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161