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 |
| Secondary identifying numbers | NOM001 |
- 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
Scientific
Department of Clinical Pharmacology (Level 7)
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Double blind, placebo controlled, crossover trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 22/06/2007 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 60 patients |
| 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
- Scotland
- United Kingdom
Study participating centre
Department of Clinical Pharmacology (Level 7)
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
11 Perth Road
Dundee
DD14HN
Scotland
United Kingdom
| Website | http://www.dundee.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
