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.

Condition	Intervention	Phase
Atherosclerosis Impaired Glucose Tolerance isolated impaired fasting glucose Cardiovascular Disease	Drug: Ramipril  Drug: Rosiglitazone	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.
Expected Total Enrollment:  1200

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.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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 chairs or principal investigators

Eva Lonn, MD,  Principal Investigator,  McMaster University   

Study ID Numbers:  STARR
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00140647
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13