Study of clot dissolving treatment for stroke that occurs during sleep

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

•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

Exclusion Criteria

•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
•Persistent blood pressure elevation (systolic =185 mmHg or diastolic =110 mmHg), despite blood pressure lowering treatment
•Blood glucose < 3.0 or > 20.0 mmol/L
•Childbearing potential, pregnancy, positive pregnancy test, breastfeeding
•Other serious or life-threatening disease before the stroke: severe mental or physical disability (e.g. Mini Mental Status score < 20, or modified Rankin Scale score = 3), or life expectancy less than 12 months
•Patient unavailability for follow-up (e.g. no fixed address)