Acute ischaemic stroke upon awakening Circulatory System
Conditions
Interventions
Patients will be randomly allocated to tenecteplase 0.25 mg/kg plus best standard treatment vs best standard treatment alone.
Treatment with open tenecteplase
The tota
Sponsors
University Hospital of North Norway
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1. Age 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome (defined by the mRS) at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical events: 1. Intracranial haemorrhage during the first 7 days 2. Stroke progression during the first 7 days 3. Recurrent ischaemic stroke during the first 7 days 4. Death from all cause during the first 7 days and during 3 months’ follow-up Clinical outcomes: Barthel Index score, EuroQol score, and Mini Mental State Examination (MMSE) scores at 3 months Health-economic variables: Costs related to: 1. Length of hospital stay 2. Nursing home care after discharge 3. Re-hospitalisations during first 3 months | — |
Countries
Denmark, Estonia, Finland, Lithuania, Norway, Sweden, Switzerland, United Kingdom
Outcome results
None listed