Awardee OrganizationUNIVERSITY OF VERMONT & ST AGRIC COLLEGE
Description
Abstract Text
The revised Bypass Angioplasty Revascularization Investigation (BARI) II study
proposes to evaluate treatments for Type 2 diabetic patients with
angiographically proven coronary artery disease and stable angina or ischemia.
For this rapidly growing patient population with very poor prognosis and
quality of life, revascularization has been less beneficial than in
nondiabetics. Using a factorial design, BARI II will compare revascularization
combined with aggressive medical anti-ischemia treatment to aggressive medical
anti-ischemia treatment alone; simultaneously, BARI II will compare two
glycemic control strategies, insulin sensitization versus insulin provision.
All patients will have target HbA1c values < 7.5%, and uniform control of
hypertension, dyslipidemia and obesity following recommended guidelines.
A total of 2,600 patients will be recruited, randomized, treated, and followed
at 30 clinical centers. Five-year mortality will be the primary endpoint
analyzed by intention-to-treat. The Coordinating Center (CC) will assume
responsibility for overall trial operations including clinical site selection,
data management using an Internet system, and statistical analysis. Within
the CC will be operational units for the management of diabetes control,
lipids and hypertension. Detailed data on potential mechanisms of
macrovascular events will be collected with centralized evaluations of ECGs,
lipids and HbA1c levels. A fibrinolysis core laboratory will explore the
effect of glycemic control strategy on the progression and mechanism of
vasculopathy, including changes in PAI-1 activity and gene expression. The
investigators will evaluate the relative economic costs associated with
revascularization approaches and diabetes control (Separate application for
the ECG Core, the Fibrinolysis Core and the Economics Core complement this
lead application). This 7-year application includes a 6-month protocol
finalization phase, 2 years of patient recruitment and an additional 4.5 years
of follow-up.
BARI II aims to answer critical scientific questions regarding treatment
efficacy in Type 2 diabetic patients with stable CAD. The investigators
further expect that this collaborative effort will translate into a new
practical clinical paradigm that will be used for treatment of Type II
diabetic patients.
No Sub Projects information available for 5U01HL063804-05
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