ISRCTN10601890已完成3 期
Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST): a randomised controlled trial of thrombolytic treatment with tenecteplase for acute ischaemic stroke upon awakening
niversity Hospital of North Norway0 个研究点目标入组 578 人开始时间: 2016年5月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 578
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33446083/ (added 23/05/2022) 2022 Results article in https://doi.org/10.1016/S1474-4422(22)00484-7 primary outcome data (added 22/12/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Stroke symptoms on awakening that were not present before sleep
- •2. Clinical diagnosis of stroke with limb weakness with NIHSS score >5, or dysphasia
- •3. Treatment with tenecteplase is possible within 4.5 hours of awakening
- •4. Written consent from the patient, non-written consent from the patient (witnessed by non-participating health care personnel), or written consent from the nearest family member
排除标准
- •1. Age <18 years
- •2. Findings on plain CT that indicate that the patient is unlikely to benefit from treatment:
- •2.1. Infarction comprising more than >1/3 of the middle cerebral artery territory on plain CT
- •2.2. Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g. cerebral tumour)
- •3. Patient will be treated with intra-arterial interventions for proximal cerebral artery occlusion
- •4. High risk of bleeding, e.g.:
- •4.1. Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
- •4.2. Any known defect in coagulation, e.g. current use of vitamin K antagonist with an INR > 1.7, or other oral anticoagulants, or heparins
- •4.3. Known defect of clotting or platelet function (but patients on antiplatelet agents can be included)
- •4.4. Ischaemic stroke in previous 2 weeks, previous intracranial haemorrhage, or known arteriovenous malformation or aneurysm
- •5. Persistent blood pressure elevation (systolic =185 mmHg or diastolic =110 mmHg), despite blood pressure lowering treatment
- •6. Blood glucose < 3.0 or > 20.0 mmol/L
- •7. Childbearing potential, pregnancy, positive pregnancy test, breastfeeding
- •8. Other serious or life-threatening disease before the stroke: severe mental or physical disability (e.g. Mini Mental Status score < 20, or mRS score = 3), or life expectancy less than 12 months
- •9. Patient unavailability for follow-up (e.g. no fixed address)
研究者
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