Status:
COMPLETED
The Study of Atherosclerosis With Ramipril and Rosiglitazone
Lead Sponsor:
Gerstein, Hertzel, MD
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Atherosclerosis
Impaired Glucose Tolerance
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00140647
Start Date
July 1 2001
End Date
July 1 2006
Last Update
August 25 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.