The Study of Atherosclerosis With Ramipril and Rosiglitazone

Phase 3

Completed

• Conditions: Atherosclerosis; Impaired Glucose Tolerance; Isolated Impaired Fasting Glucose; Cardiovascular Disease

• Registration Number: NCT00140647
• Lead Sponsor: Gerstein, Hertzel, MD

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Completion: 2006-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-21
• Last Update Posted: 2008-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• impaired glucose tolerance (FPG < 7 mmol/L or 126 mg/dL & 2hr PG between 7.8-11.0 mmol/l [140-199 mg/dl] after a 75 g OGTT
• impaired glucose tolerance (FPG≥ 6.1 mmol/l [110 mg/dl]) and no diabetes (i.e. a FPG < 7.0 mmol/l [126 mg/dl])
• a technically adequate baseline carotid ultrasound examination

Exclusion Criteria

• current use of an ACE-inhibitor (ACE-I) or thiazolidinedione (TZD)
• known hypersensitivity to ACE-I
• prior use of anti-diabetic medications 9with the exception of during pregnancy)
• use of systemic glucocorticoids or niacin
• congestive heart failure or EF < 40%
• existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
• diabetes
• renal or hepatic disease
• major illness
• use of another experimental drug
• pregnant or unwilling to use reliable contraception
• major psychiatric disorder
• diseases that affect glucose tolerance
• unwillingness to be randomized or sign informed consent
• known uncontrolled substance abuse
• inability to communicate with research staff

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
The change of the mean maximum carotid intimal medial thickness (IMT)evaluated across 12 segments involving the left and right common carotid, bifurcation and internal carotid arteries.

Secondary Outcome Measures

Name	Time	Method
The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.