Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140647
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
2005-08-30
Brief Title:
The Study of Atherosclerosis With Ramipril and Rosiglitazone
Sponsor:
Gerstein Hertzel MD
Organization:
Gerstein Hertzel MD
Study Overview
Official Title:
The Study of Atherosclerosis With Ramipril and Rosiglitazone
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if ramipril andor 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 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 1200 study participants and follow is proposed for an average of 375 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None