Rosiglitazone Versus Placebo in Chronic Stable Angina

Angina Pectoris Clinical Trial

Official title:

Insulin Sensitisation as a Novel Mechanism to Lessen Ischaemic Burden in Overweight Non-Diabetic Patients With Chronic Stable Angina: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225355
• Other study ID #: GlasUniRosiPlacebo
• Secondary ID: Eudract no. 2004
• Status: Terminated
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: February 18, 2009
• Start date: February 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2009
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Metabolic Syndrome X

Intervention

Drug:
• Rosiglitazone

Locations

Country	Name	City	State
United Kingdom	Cardiology Department, Glasgow Royal Infirmary	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
University of Glasgow	British Heart Foundation, GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in angina status at three months
Secondary	Change in pulse wave velocity at three months
Secondary	Change in small vessel function at three months
Secondary	Change in markers of haemostasis at three months
Secondary	Change in biochemical markers of insulin resistance/metabolic syndrome at three months
Secondary	Change in blood pressure at three months
Secondary	Change in anthropometric status at three months