Back to resultsRosiglitazone Versus Placebo in Chronic Stable Angina
Primary Purpose
Angina Pectoris, Metabolic Syndrome X
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris focused on measuring Angina pectoris, Metabolic syndrome, Ischaemic heart disease
Eligibility Criteria
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
Sites / Locations
- Cardiology Department, Glasgow Royal Infirmary
Outcomes
Primary Outcome Measures
Change in angina status at three months
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00225355
First Posted
September 21, 2005
Last Updated
February 18, 2009
Sponsor
University of Glasgow
Collaborators
British Heart Foundation, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00225355
Brief Title
Rosiglitazone Versus Placebo in Chronic Stable Angina
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 Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Glasgow
Collaborators
British Heart Foundation, GlaxoSmithKline
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Metabolic Syndrome X
Keywords
Angina pectoris, Metabolic syndrome, Ischaemic heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Primary Outcome Measure Information:
Title
Change in angina status at three months
Secondary Outcome Measure Information:
Title
Change in pulse wave velocity at three months
Title
Change in small vessel function at three months
Title
Change in markers of haemostasis at three months
Title
Change in biochemical markers of insulin resistance/metabolic syndrome at three months
Title
Change in blood pressure at three months
Title
Change in anthropometric status at three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveed Sattar, MBChB PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart M Cobbe, MBChB MD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department, Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
12. IPD Sharing Statement
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Rosiglitazone Versus Placebo in Chronic Stable Angina
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