Allopurinol, brain lesions, heart size and blood pressure after ischaemic stroke

Phase 1

• Conditions: Ischaemic stroke or transient ischaemic attack (TIA) (ICD Classification Code I63.0-9 and G45.0-1); MedDRA version: 21.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10044390Term: Transient ischaemic attackSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-004235-77-GB
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-12
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1. Ischaemic Stroke.
2. Age greater than 50 years.
3. Ischaemic lesion on brain imaging in relevant anatomical territory in patients with transient ischaemic attack.
4. Consent within one month of stroke.

Ischaemic stroke will be diagnosed by a stroke specialist and defined as a focal neurological event lasting more than 24 hours or symptoms lasting less than 24 hours with positive diffusion weighted imaging or a corresponding lesion on CT. This inclusion criterion will be verified by local investigators following image review and this will be recorded in the patient record and on the eCRF.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 364

Exclusion Criteria

1. Modified Rankin scale score of 5 (at end of the possible enrolment window of one month after stroke).
2. Diagnosis of dementia (defined as a documented diagnosis or a screening IQCODE (Informant Questionnaire for Cognitive Decline in the Elderly) score of 3.6 or more).
3. Cognitive impairment deemed sufficient to compromise capacity to consent or to comply with the protocol (in the opinion of the local investigator).
4. Dependent on daily help from others for basic or instrumental activities of daily living prior to stroke (defined as assistance needed with toileting, walking or dressing).
5. Significant co-morbidity or frailty likely to cause death within 24 months or likely to make adherence to study protocol difficult for participant (in the opinion of the local investigator).
6. Contra-indication to or indication for administration of allopurinol (as detailed in Summary of Product Characteristics on the XILO-FIST web portal and in trial master file).
7. Concurrent azathioprine, 6-mercaptopurine therapy, other cytotoxic therapies, cyclosporin, theophylline and didanosine.
8. Significant hepatic impairment (defined as serum bilirubin, AST or ALT greater than three times upper limit of normal (ULN)).
9. Estimated Glomerular Filtration Rate < 30 mls/min
10. Contraindication to MRI scanning.
11. Women of childbearing potential.
12. Prisoners.
13. Active participation in another CTIMP or device trial or participation within the past month.
14. eGFR < 60 and of Korean, Han Chinese or Thai descent

Women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for greater than 12 months and has an FSH greater than 40 IU/L

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified