Overview

Rosiglitazone Versus Placebo in Chronic Stable Angina

Status:
Terminated
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
Summary
We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects who do not have overt diabetes. The drug will be given for 3 months and the subjects will be have their angina tested, by way of exercise testing, angina quality of life questionnaire and 24-hour ECG monitoring before and after using the drug.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Glasgow
Collaborators:
British Heart Foundation
GlaxoSmithKline
Treatments:
Rosiglitazone
Criteria
Inclusion Criteria:

- Chronic stable angina - to see if this improves

- Previous positive exercise tolerance test - to ensure that repeating it yields a
result

- Disease not suitable for coronary intervention (Coronary artery bypass grafting or
angioplasty) - so that best routine care is not withheld

- Do not have overt diabetes - work on this is being undertaken elsewhere

- Body mass index (BMI) greater than 25

Exclusion Criteria:

- Diabetes mellitus - see above

- Liver failure (ALT>70U/l, AST>80U/l)

- Renal failure (creatinine > 130mmol/l)

- Cardiac failure - rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac
failure

- Physical disability - if it precludes treadmill testing

- Women of child bearing capacity

- Breast feeding mothers