Status:
TERMINATED
The Norwegian Tenecteplase Stroke Trial 2
Lead Sponsor:
Haukeland University Hospital
Conditions:
Stroke, Acute
Cerebrovascular Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background: Alteplase is the only approved acute drug treatment in ischemic stroke and aims at dissolving arterial clots causing cerebral ischemia. The overall benefit of alteplase is substantial. How...
Detailed Description
Objectives: To compare efficacy and safety of tenecteplase 0.4 mg/kg (single bolus) vs. alteplase 0.9 mg/kg (10% bolus + 90% infusion/60 minutes) a) within 4½ hours after symptom onset; b) within 4½ h...
Eligibility Criteria
Inclusion
- General inclusion criteria
- 18 years or older
- Ischaemic stroke with clinical symptoms corresponding to National Institutes of Health Stroke Scale Score (NIHSS) 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.
- Informed consent by patient or by patient's family
- Specific sub-set inclusion criteria
- Wake-Up Stroke: FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist or neurologist.
- Thrombectomy: Occlusion of intracerebral artery technically accessible for endovascular embolectomy as defined by local treatment protocols.
- Exclusion criteria
- Prestroke modified rankin scale of ≥3
- 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)
- Beast feeding 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.
Exclusion
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03854500
Start Date
October 28 2019
End Date
December 31 2021
Last Update
March 3 2025
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Norway, 5021