New therapeutic targets in stroke prevention: the effects of allopurinol on the cerebrovasculature of patients with subcortical stroke
| ISRCTN | ISRCTN06452574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06452574 |
| Protocol serial number | N/A |
| Sponsor | Greater Glasgow NHS Board/Glasgow University (UK) |
| Funder | West Endowment Fund (UK) |
- Submission date
- 09/09/2005
- Registration date
- 22/11/2005
- Last edited
- 01/02/2010
- 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 Matthew Walters
Scientific
Scientific
Department of Medicine & Therapeutics
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom
| Phone | +44 (0)141 211 2821 |
|---|---|
| gcl203@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Treatment with xanthine oxydase inhibitor allopurinol will improve cerebrovascular reactivity in patients with subcortical stroke. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Subcortical stroke. |
| Intervention | 3 month allopurinol treatment (300 mg) versus lactose tablet. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Allopurinol |
| Primary outcome measure(s) |
The change in flow velocity in the middle cerebral artery (MCA) following acetazolomide infusion. |
| Key secondary outcome measure(s) |
1. Change in serum urate |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Subcortical stroke 2. Index stroke within 2 weeks and 3 months prior to randomisation |
| Key exclusion criteria | 1. >70% Internal carotid artery stenosis 2. Coronary artery disease 3. Other significant comorbidity 4. Contraindication to allopurinol 5. Contraindication to acetazolamide 6. Concurrent azathioprine or 6-mercaptopurine therapy 7. Serum creatinine >250 µmol/l 8. Woman of childbearing potential |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom
G11 6NT
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 | 01/11/2009 | Yes | No |
