Cardiovascular Disease Clinical Trial
Official title:
The Study of Atherosclerosis With Ramipril and Rosiglitazone
The purpose of this study is to determine if ramipril and/or rosiglitazone retard the progression of atherosclerosis as evaluated by serial carotid intermedial thickness measurements.
STARR is a multi-centre, international, randomized controlled clinical trial with a 2x2
factorial design, that will evaluate the effects of ramipril and of rosiglitazone on
atherosclerosis progression, as determined by B-mode carotid ultrasound (US). It is designed
as a substudy of DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone
Medications) Trial. The study is designed to enroll 1,200 study participants and follow is
proposed for an average of 3.75 years.
SIGNIFICANCE OF THE PROPOSED RESEARCH: With regards to ramipril this study will provide
important mechanistic data regarding potential benefits of ACE inhibitor therapy on
atherosclerosis and by inference in reducing CV risk in a lower risk younger population than
studied in previous trials. In this population a clinical outcome trial focusing primarily
on CV events would be difficult to conduct due to the expected fairly low event rate. If the
study on atherosclerosis is positive, this may provide a rational for therapy in this subset
of patients without overt CVD or diabetes, but with impaired glucose tolerance or impaired
fasting glucose.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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