The Study of Atherosclerosis With Ramipril and Rosiglitazone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00140647|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 25, 2008
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Impaired Glucose Tolerance Isolated Impaired Fasting Glucose Cardiovascular Disease||Drug: Ramipril Drug: Rosiglitazone||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||The Study of Atherosclerosis With Ramipril and Rosiglitazone|
|Study Start Date :||July 2001|
|Study Completion Date :||July 2006|
- 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.
- The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140647
|Principal Investigator:||Eva Lonn, MD||McMaster University|