Do Xanthine Oxidase Inhibitors (XOI) have clinically useful anti-ischaemic effects in the treatment of angina pectoris? A double-blind, placebo controlled trial

ISRCTN	ISRCTN82040078
DOI	https://doi.org/10.1186/ISRCTN82040078
Protocol serial number	NOM001
Sponsor	University of Dundee (UK)
Funder	British Heart Foundation (UK)

Submission date: 22/06/2007
Registration date: 26/06/2007
Last edited: 15/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Awsan Noman
Scientific

Department of Clinical Pharmacology (Level 7)
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Study information

Primary study design	Interventional
Study design	Double blind, placebo controlled, crossover trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Investigating if allopurinol (a Xanthine Oxidase Inhibitor [XOI]) has anti-ischaemic effects in the treatment of chronic stable angina patients.
Ethics approval(s)	Approved by Tayside Committee on Medical Ethics in November 2006 (ref: 06/S1401/133).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Allopurinol (a Xanthine Oxidase Inhibitor [XOI])
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	60
Key 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
Key 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)
Date of first enrolment	22/06/2007
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Clinical Pharmacology (Level 7)

Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/06/2010		Yes	No