EUCTR2013-004235-77-GB进行中（未招募）1 期
Xanthine oxidase inhibition for improvement of long-term outcomes following ischaemic stroke and transient ischaemic attack (XILO-FIST). - XILO-FIST
HS Greater Glasgow & Clyde0 个研究点目标入组 464 人开始时间: 2015年3月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 464
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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