Trials / Unknown
UnknownNCT00123227
Rosiglitazone Plaque Study
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
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 and/or 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rosiglitazone |
Timeline
- Start date
- 2002-10-01
- Completion
- 2005-05-01
- First posted
- 2005-07-22
- Last updated
- 2005-08-01
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00123227. Inclusion in this directory is not an endorsement.