Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NOM001
Study information
Scientific title
Acronym
Study hypothesis
Investigating if allopurinol (a Xanthine Oxidase Inhibitor [XOI]) has anti-ischaemic effects in the treatment of chronic stable angina patients.
Ethics approval
Approved by Tayside Committee on Medical Ethics in November 2006 (ref: 06/S1401/133).
Study design
Double blind, placebo controlled, crossover trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary Artery Disease - patients with chronic stable angina
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Allopurinol (a Xanthine Oxidase Inhibitor [XOI])
Primary outcome measure
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).
Secondary outcome measures
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).
Overall trial start date
22/06/2007
Overall trial end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60 patients
Participant exclusion criteria
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)
Recruitment start date
22/06/2007
Recruitment end date
01/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Pharmacology (Level 7)
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
11 Perth Road
Dundee
DD14HN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20542554
Publication citations
-
Results
Noman A, Ang DS, Ogston S, Lang CC, Struthers AD, Effect of high-dose allopurinol on exercise in patients with chronic stable angina: a randomised, placebo controlled crossover trial., Lancet, 2010, 375, 9732, 2161-2167, doi: 10.1016/S0140-6736(10)60391-1.