Acute ischaemic stroke upon awakening ("wake-up stroke") MedDRA version: 20.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Metalyse
Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled syringe
INN or Proposed INN: TENECTEPLASE
CAS Number: 191588-94-0
Concentration unit: IU/g interna
Sponsors
University or Tromsø
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • Age 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To answer the following question: - Can thrombolytic treatment with tenecteplase given within 4.5 hours of wake-up reduce the risk of poor functional outcome at 3 months? ;Secondary Objective: To answer the following question: - Can findings on plain CT and CT angiography (and CT perfusion at selected centres) identify patients who benefit from such treatment, compared to patients without such findings? ;Primary end point(s): Functional outcome (defined by the modified Rankin Scale) ;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical events: • Intracranial haemorrhage during the first 7 days • Stroke progression during the first 7 days • Recurrent ischaemic stroke during the first 7 days • Death from all cause during the first 7 days and during 3 months’ follow-up Clinical outcomes: Barthel Index score, EuroQol score, and MMSE scores at 3 months. Health-economic variables: Costs related to length of hospital stay, care in nursing home etc., re-hospitalisations during first 3 months;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Denmark, Finland, Lithuania, United Kingdom
Contacts
Public ContactEivind Berge
Oslo University Hospital
Outcome results
None listed