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Rosiglitazone Versus Placebo in Chronic Stable Angina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225355
Recruitment Status : Terminated
First Posted : September 23, 2005
Last Update Posted : February 19, 2009
British Heart Foundation
Information provided by:
University of Glasgow

Brief 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.

Condition or disease Intervention/treatment Phase
Angina Pectoris Metabolic Syndrome X Drug: Rosiglitazone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Insulin Sensitisation as a Novel Mechanism to Lessen Ischaemic Burden in Overweight Non-Diabetic Patients With Chronic Stable Angina: A Pilot Study
Study Start Date : February 2006
Estimated Study Completion Date : November 2006

Primary Outcome Measures :
  1. Change in angina status at three months

Secondary Outcome Measures :
  1. Change in pulse wave velocity at three months
  2. Change in small vessel function at three months
  3. Change in markers of haemostasis at three months
  4. Change in biochemical markers of insulin resistance/metabolic syndrome at three months
  5. Change in blood pressure at three months
  6. Change in anthropometric status at three months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225355

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United Kingdom
Cardiology Department, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
University of Glasgow
British Heart Foundation
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Principal Investigator: Naveed Sattar, MBChB PhD University of Glasgow
Principal Investigator: Stuart M Cobbe, MBChB MD University of Glasgow

Layout table for additonal information Identifier: NCT00225355    
Other Study ID Numbers: GlasUniRosiPlacebo
Eudract no. 2004-000949-38
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009
Keywords provided by University of Glasgow:
Angina pectoris
Metabolic syndrome
Ischaemic heart disease
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs