The Study of Atherosclerosis With Ramipril and Rosiglitazone

Gerstein, Hertzel, MD

Status and phase

Completed

Phase 3

Conditions

Impaired Glucose Tolerance

Isolated Impaired Fasting Glucose

Atherosclerosis

Cardiovascular Disease

Treatments

Drug: Rosiglitazone

Drug: Ramipril

Study type

Interventional

Funder types

Other

Identifiers

NCT00140647

STARR

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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