Rosiglitazone Versus Placebo in Chronic Stable Angina

University of Glasgow

Status and phase

Terminated

Phase 4

Conditions

Angina Pectoris

Metabolic Syndrome X

Treatments

Drug: Rosiglitazone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00225355

GlasUniRosiPlacebo

Eudract no. 2004-000949-38

Details and patient eligibility

About

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.

Full description

Chronic stable angina is a common manifestation of ischaemic heart disease. Current mechanical therapies (percutaneous coronary intervention and coronary artery bypass grafting) and pharmacological therapies (nitrates, calcium channel blockers, betablockers and potassium channel activators) main actions are to treat the end product of ischaemic heart disease on chronic stable angina, i.e. the flow limiting stenosis. We postulate that by treating insulin resistance, an upstream factor in the pathogenesis of ischaemic heart disease, we will improve angina by in turn improving endothelial function. We will attempt to demonstrate this by way of full bruce protocol exercise tolerance test, Seattle Angina Questionnaire and 24 hour ST segment analysis before and after treatment with the insulin sensitiser rosiglitazone for three months.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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