Rosiglitazone Versus Placebo in Chronic Stable Angina

NCT00225355 | Terminated Phase 4

• 2 other identifiers: GlasUniRosiPlaceboEudract no. 2004-000949-38
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris; Metabolic Syndrome X

Keywords

Angina pectoris; Metabolic syndrome; Ischaemic heart disease

Outcome Measures

Primary Outcomes (1)

• Change in angina status at three months

Secondary Outcomes (6)

• 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

Interventions

Rosiglitazone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• British Heart Foundation: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Cardiology Department, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Angina Pectoris; Metabolic Syndrome; Coronary Artery Disease

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Naveed Sattar, MBChB PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Stuart M Cobbe, MBChB MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: February 1, 2006
• Study Completion: November 1, 2006
• Last Updated: February 19, 2009

Record last verified: 2009-02

Locations

GB (1)