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ISRCTN
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ISRCTN82040078
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ClinicalTrials.gov identifier
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Public title
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Do Xanthine Oxidase Inhibitors (XOI) have clinically useful anti-ischaemic effects in the treatment of angina pectoris? A double-blind, placebo controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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NOM001
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Study hypothesis
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Investigating if allopurinol (a Xanthine Oxidase Inhibitor [XOI]) has anti-ischaemic effects in the treatment of chronic stable angina patients.
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Ethics approval
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Approved by Tayside Committee on Medical Ethics in November 2006 (ref: 06/S1401/133).
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Study design
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Double blind, placebo controlled, crossover trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Coronary Artery Disease - patients with chronic stable angina
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Participants - inclusion criteria
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1. Documented Coronary artery Disease (CAD) on angiography
2. Chronic stable angina (greater than two months)
3. Able to do Exercise Treadmill Test (ETT)
4. Aged between 30 and 85 years
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Participants - exclusion criteria
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1. Contra-indication or unable to do ETT
2. Already on allopurinol or previous allergy to allopurinol
3. Left Ventricular (LV) ejection fraction less than 45%
4. Myocardial Infarction (MI) or Acute Coronary Syndrome (ACS) over the last two months
5. Change to anti-anginal therapy over the last month
6. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) within the last six months
7. Significant renal or hepatic impairment
8. On medication that may interact with allopurinol (e.g., warfarin)
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Anticipated start date
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22/06/2007
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Anticipated end date
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01/09/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60 patients
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Interventions
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Drug: allopurinol 300 mg - 600 mg given for six weeks.
Allopurinol (the intervention drug) is given orally (p.o.). Starting dose is 100 mg once daily (od). This is escalated over two weeks to a maximum dose of 300 mg twice daily (bd), which is given for a further period of four weeks (total six weeks). With regards to the control group, this trial is of a crossover design so each patient will be his/her own control. The placebo will be given in exactly the same fashion as the allopurinol for a total period of six weeks.
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Primary outcome measure(s)
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Time to ST depression on ETT.
Outcomes will be assessed at the start and every six weeks (at the end of each treatment period - allopurinol or placebo).
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Secondary outcome measure(s)
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1. Total exercise time
2. Time to symptom on ETT
3. Assessment of angina
4. Measurement of C-Reactive Protein (CRP), B-type Natriuretic Peptide (BNP) and Procollagen III N-terminal Peptide (PIIINP)
Outcomes will be assessed at the start and every six weeks (at the end of each treatment period - allopurinol or placebo).
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Sources of funding
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British Heart Foundation (UK)
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Trial website
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Publications
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Contact name
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Dr
Awsan
Noman
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Address
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Department of Clinical Pharmacology (Level 7)
Ninewells Hospital and Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Sponsor
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University of Dundee (UK)
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Address
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11 Perth Road
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City/town
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Dundee
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Zip/Postcode
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DD14HN
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Country
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United Kingdom
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Sponsor website:
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http://www.dundee.ac.uk/
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Date applied
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22/06/2007
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Last edited
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26/06/2007
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Date ISRCTN assigned
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26/06/2007
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