Condition category
Circulatory System
Date applied
22/06/2007
Date assigned
26/06/2007
Last edited
15/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Awsan Noman

ORCID ID

Contact details

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

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 measures

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

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

http://www.dundee.ac.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20542554

Publication citations

  1. 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.

Additional files

Editorial Notes