Rosiglitazone Plaque Study
|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: NCT00123227|
Recruitment Status : Unknown
Verified May 2005 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : July 22, 2005
Last Update Posted : August 1, 2005
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Vascular Diseases Hypertension||Drug: Rosiglitazone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||October 2002|
|Estimated Study Completion Date :||May 2005|
- Plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR)
- Change in plaque lipid content
- Change in plaque fibrous cap thickness
- Change in plaque gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation
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): NCT00123227
|Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|St Mary's NHS Trust|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Dudley J Pennell, MD FRCP FACC||Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital, London UK / National Heart and Lung Institute, Imperial College, London UK|