Angina PectorisPhase 4NCT00225355
Rosiglitazone Versus Placebo in Chronic Stable Angina
A Phase 4 study testing Rosiglitazone in people with Angina Pectoris and Metabolic Syndrome X, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Metabolic Syndrome X
- What is being tested?
- Rosiglitazone
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiology Department, Glasgow Royal Infirmary
Glasgow, G4 0SF
About this study
Official title: 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.
Read the 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.
- Conditions
- Angina Pectoris, Metabolic Syndrome X
- Being tested
- Rosiglitazone
- Keywords
- Angina pectoris, Metabolic syndrome, Ischaemic heart disease
- Medical subject headings
- Angina Pectoris, Metabolic Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Change in anthropometric status at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startFeb 2006
- Study completionNov 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, GlaxoSmithKline
- Investigators
- Naveed Sattar, MBChB PhD, Principal investigator, University of GlasgowStuart M Cobbe, MBChB MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225355
- Sponsor's protocol ID
- GlasUniRosiPlacebo
- Other IDs
- Eudract no. 2004-000949-38
- Status last verified
- Feb 2009
- First submitted
- 21 Sep 2005
- Last updated
- 19 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitisation as a Novel Mechanism to Lessen Ischaemic Burden in Overweight Non-Diabetic Patients With Chronic Stable Angina: A Pilot Study
- ClinicalTrials.gov ID
- NCT00225355
- Acronym / sponsor ID
- GlasUniRosiPlacebo
- Conditions
- Angina Pectoris, Metabolic Syndrome X
- Keywords
- Angina pectoris, Metabolic syndrome, Ischaemic heart disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- British Heart Foundation, GlaxoSmithKline
- Study start
- Feb 2006
- Study completion
- Nov 2006 (estimated)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosiglitazone | Drug | – |
Primary outcome
Change in angina status at three months
6 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveed Sattar, MBChB PhD principal investigator
University of Glasgow
Stuart M Cobbe, MBChB MD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosiglitazone in people with Angina Pectoris and Metabolic Syndrome X, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in angina status at three months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009.