Rosiglitazone Versus Placebo in Chronic Stable Angina

February 18, 2009 updated by: University of Glasgow

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • Cardiology Department, Glasgow Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in angina status at three months

Secondary Outcome Measures

Outcome Measure
Change in pulse wave velocity at three months
Change in small vessel function at three months
Change in markers of haemostasis at three months
Change in biochemical markers of insulin resistance/metabolic syndrome at three months
Change in blood pressure at three months
Change in anthropometric status at three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

GlaxoSmithKline
British Heart Foundation

Investigators

  • Principal Investigator: Naveed Sattar, MBChB PhD, University of Glasgow
  • Principal Investigator: Stuart M Cobbe, MBChB MD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Anticipated)

November 1, 2006

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 18, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlasUniRosiPlacebo
  • Eudract no. 2004-000949-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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