Status:
COMPLETED
Prevention of Instent Renarrowing With Aggressive Glucose Lowering With Pioglitazone in Diabetic Patients
Lead Sponsor:
Queen Elizabeth II Health Sciences Centre
Collaborating Sponsors:
Nova Scotia Health Research Foundation
Conditions:
Coronary Artery Disease
Angina Pectoris
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
Patients with diabetes have worse outcomes after percutaneous coronary intervention (PCI) procedures, compared to those patients without diabetes. They are at increased risk of death, heart attack, or...
Detailed Description
Background: Despite drug-eluting stents (DES), diabetic patients remain at high risk of restenosis and poor clinical outcomes after percutaneous coronary intervention (PCI). Studies have suggested poo...
Eligibility Criteria
Inclusion
- between the ages 30 to 80 years
- had type 2 diabetes mellitus treated with diet or oral hypoglycemic agents (OHA: sulfonylurea or metformin alone or the combination of sulfonylurea or metformin as long as metformin dose was \< 2000 mg/d)
- All patients were undergoing either elective or urgent PCI of a de novo native coronary lesion (\> 70 % diameter stenosis) in a vessel ≥ 2.5 mm diameter that was felt to be suitable for stenting and an IVUS examination.
Exclusion
- left main \> 50 % stenosis
- ongoing congestive heart failure or left ventricular ejection fraction \< 30%
- primary PCI for ST elevation MI
- use of insulin or thiazolidinedione therapy (rosiglitazone or pioglitazone) immediately before PCI
- known intolerance to thiazolidinediones
- creatinine \> 130 µmol/L
- significant liver disease: ALT or AST \> 3 times upper limit of normal, history of cirrhosis, or hepatitis
- women who were pregnant, breastfeeding, or childbearing potential
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00819325
Start Date
August 1 2002
End Date
March 1 2007
Last Update
January 8 2009
Active Locations (1)
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1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7