A phase III, randomized, multi-center clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging.
Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment with Alteplase due to onset >4.5 hours and is ineligible for endovascular treatment under standard of care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and dominant M2 segments, and vertebrobasilar arteries).
No significant pre-stroke functional disability (mRS ≤2).
Age ≥18 years (no upper age limit).
Significant cortical neurological deficit (moderate to severe afasia, moderate to severe heminegligence, severe hemianopsia) with the addition or not of motor symptoms OR any motor deficit accompanied of cortical symptoms of any severity;
Intracranial hemorrhage (ICH) identified by CT or MRI.
Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient without eligibility criteria.
Pre-stroke mRS score of ≥ 2 (indicating previous disability)
Contra indication to imaging with MR or CT with contrast agents.
Parallel
Intravenous tenecteplase
DrugIntravenous tenecteplase (TNK). Patients will receive intravenous TNK (0.25mg/kg, maximum 25mg, administered as a bolus over 5 seconds).
Placebo
DrugPlacebo matching IV TNK
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days as following: Baseline mRS=0 and NIHSS \<10: mRs 90 days ≤1 Baseline mRS=1 and NIHSS ≥10: mRs 90 days ≤2
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Cost effectiveness analysis of IV TNK vs standard medical therapy
Cost effectiveness analysis of IV TNK vs standard medical therapy
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Hospital Moinhos de Vento
Lead sponsor
Ministry of Health, Brazil
Collaborator
Boehringer Ingelheim
Collaborator
Brainomix Limited
Collaborator
iSchemaView, Inc
Collaborator
