Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123227
Status:
UNKNOWN
Last Update Posted:
2005-08-01
First Post:
2005-07-19
Brief Title:
Rosiglitazone Plaque Study
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled Cardiovascular Magnetic Resonance CMR Study to Evaluate the Effect of Rosiglitazone on Carotid Atherosclerotic Plaques in Type 2 Diabetics With Vascular Disease or Hypertension
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 whether rosiglitazone a peroxisome proliferator activated receptor gamma PPAR-gamma agonist induces regression in carotid atherosclerotic plaques in diabetic patients with vascular disease andor hypertension over a 12 month period
Detailed Description:
Rosiglitazone is a new member of the thiazolidinediones TZDs a class of drugs which act by binding to peroxisome proliferator activated receptor gamma PPAR-gamma It has been suggested that the TZD class od anti-diabetic drug may exhibit anti-atherosclerotic effects The aim of this study is to evaluate over a 12 month period the potential benefits of rosiglitazone on carotid artery atherosclerotic plaques in the type 2 diabetic population with coexisting vascular disease or hypertension It is hypothesised that treatment with rosiglitazone will lead to a decrease in plaque size In addition it is hoped that rosiglitazone will have a positive effect on the plaque composition and stability
The primary endpoint will be the plaque volume change over 12 months as assessed by cardiovascular magnetic resonance CMR The effectiveness of this modality to evaluate the effects of pharmacological agents on atherosclerosis in vivo has been demonstrated in previous studies using statins
The secondary endpoints will be to define the changes in plaque lipid content fibrous cap thickness and gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation
The primary endpoint will be the plaque volume change over 12 months as assessed by cardiovascular magnetic resonance CMR The effectiveness of this modality to evaluate the effects of pharmacological agents on atherosclerosis in vivo has been demonstrated in previous studies using statins
The secondary endpoints will be to define the changes in plaque lipid content fibrous cap thickness and gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation
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