The Study of Atherosclerosis With Ramipril and Rosiglitazone (NCT00140647) | Clinical Trial Compass
CompletedPhase 3
The Study of Atherosclerosis With Ramipril and Rosiglitazone
1,200 participantsStarted 2001-07
Plain-language 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.
Who can participate
Age range30 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (FPGā„ 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
What they're measuring
1
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.