Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST) - TWIST

niversity or Tromsø0 sites500 target enrollmentNovember 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

November 23, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity or Tromsø

•Stroke symptoms on awakening that were not present before sleep
•Clinical diagnosis of stroke with limb weakness with NIHSS score \>5, or dysphasia.
•Treatment with tenecteplase is possible within 4\.5 hours of awakening
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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 400

•Age \< 18 years
•Findings on plain CT that indicate that the patient is unlikely to benifit from treatment:
•\-Infarction comprising more than \>1/3 of the middle cerebral artery territory on plain CT
•\-Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g cerebral tumour)
•Patient will be treated with intra\-arterial interventions for proximal cerebral artery occlusion
•High risk of bleeding, e.g.:
•\-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.
•\-Any known defect in coagulation, e.g. current use of vitamin K antagonist with an INR \> 1\.7, or other oral anticoagulant, or heparins
•\-Known defect of clotting or platelet function (but patients on antiplatelet agents can be included)
•\-Ischaemic stroke in previous 2 weeks, previous intracranial haemorrhage, or known arteriovenous malformation or aneurysm