The Norwegian Tenecteplase Stroke Trial 2 ( NOR-TEST 2 )Tenecteplase in Acute Stroke 2

Phase 1

• Conditions: Ischeamic stroke; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003090-95-NO
• Lead Sponsor: Helse Bergen HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1342

Inclusion Criteria

General inclusion criteria
•Age 18 years or older admitted to hospital with an acute ischaemic stroke
•Ischaemic stroke with clinical symptoms corresponding to a NIHSS score of >5.
•All stroke sub-types and vascular distributions are eligible.
•A visible arterial occlusion is not required for inclusion.
•Treatment <4½ hours after stroke onset or after awakening with symptoms.
•Beastfeeding women, if a 24 hours stop of feeding is feasible.

Specific sub-set inclusion criteria
•Wake-Up Stroke: FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist or neurologist.
•Thrombectomy: Occlusion of an intracerebral artery, technically accessible for endovascular embolectomy as defined by local treatment protocols.
•Signed informed consent and expected cooperation of the patients must be obtained and documented according to ICH GCP, and national/local regulations. A written or signed informed consent before thrombolytic treatment is not necessary, but must be obtained before entering data into the research data base.

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 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
•Large areas of hypodense ischaemic changes on baseline CT;
•Patients with systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg in spite of acute antihypertensive treatment;
•Pregnant women (are treated with alteplase);
•Women with possible pregnancy (are treated with alteplase)
•Beastfeeding women, if a 24 hours stop of feeding is not feasible.
•Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal;
•Known bleeding diathesis; use of oral anticoagulants with no antidot, INR =1,4; heparin <48 hours and increased APTT; low molecular weight heparin(oid) <24 hours; another investigational drug <14 days;
•Patients with arterial puncture at a noncompressible site or lumbar puncture <7 days; major surgery or serious trauma <14 days; gastrointestinal or urinary tract hemorrhage <14 days; clinical stroke <2 months; history of intracranial haemorrhage; CNS neurosurgery <2 months; serious head trauma <2 months; pericarditis; sepsis; any serious medical illness likely to interact with treatment; confounding pre-existent neurological or psychiatric disease; unlikely to complete follow-up;
•Any condition that, in the opinion of the investigator, puts a patient at risk if treated with thrombolysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified