ISRCTN10601890
Completed
Phase 3
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 sites578 target enrollmentMay 31, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital of North Norway
- Enrollment
- 578
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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Phase 3
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