Tenecteplase in Wake-up Ischaemic Stroke Trial

Phase 3

Completed

• Conditions: Acute ischaemic stroke upon awakening; Circulatory System

• Registration Number: ISRCTN10601890
• Lead Sponsor: niversity Hospital of North Norway

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-31
• Study Completion: 2022-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 578

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
5. Persistent blood pressure elevation (systolic =185 mmHg or diastolic =110 mmHg), despite blood pressure lowering treatment
6. Blood glucose < 3.0 or > 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified