Rosiglitazone Versus Placebo in Chronic Stable Angina

This study has been terminated.
Sponsor:
Collaborators:
British Heart Foundation
GlaxoSmithKline
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00225355
First received: September 21, 2005
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Angina Pectoris
Metabolic Syndrome X
Drug: Rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

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

Estimated Enrollment: 80
Study Start Date: February 2006
Estimated Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225355

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

No publications provided

ClinicalTrials.gov Identifier: NCT00225355     History of Changes
Other Study ID Numbers: GlasUniRosiPlacebo, Eudract no. 2004-000949-38
Study First Received: September 21, 2005
Last Updated: February 18, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Glasgow:
Angina pectoris
Metabolic syndrome
Ischaemic heart disease

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Hyperinsulinism
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014