Rosiglitazone Versus Placebo in Chronic Stable Angina

NCT ID: NCT00225355

Last Updated: 2009-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Angina Pectoris Metabolic Syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role lead

Principal Investigators

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Naveed Sattar, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Stuart M Cobbe, MBChB MD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Cardiology Department, Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Eudract no. 2004-000949-38

Identifier Type: -

Identifier Source: secondary_id

GlasUniRosiPlacebo

Identifier Type: -

Identifier Source: org_study_id

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