To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.
Male or female subjects (age ≥ 18 years).
Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.
Time from stroke onset or last known well to randomization is 4.5 to 24 hours.
NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.
Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).
History of stroke within the last 3 months.
History of intracranial hemorrhage.
Suspected subarachnoid hemorrhage.
Parallel
Tenecteplase (0.25mg/kg)
DrugTenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Delayed dual antiplatelet therapy (initiated 24 hours after thrombolysis: Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)
Standard Medical Management
DrugImmediate dual antiplatelet therapy (Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
Proportion of patients with mRS 0-2 at 90 days.
Proportion of patients with mRS 0-2 at 90 days.
Distribution of mRS score at 90 days.
Distribution of mRS score at 90 days.
Rate of vessel recanalization.
Rate of vessel recanalization.
Proportion of patients undergoing rescue mechanical thrombectomy.
Proportion of patients undergoing rescue mechanical thrombectomy.
Increase in NIHSS score ≥4 points within 24 hours, excluding intracranial hemorrhage.
Increase in NIHSS score ≥4 points within 24 hours, excluding intracranial hemorrhage.
Symptomatic intracranial hemorrhage (sICH) at 36 hours (ECASS III definition).
Symptomatic intracranial hemorrhage (sICH) at 36 hours (ECASS III definition).
sICH within 90 days (ECASS III definition).
sICH within 90 days (ECASS III definition).
PH2 intracranial hemorrhage within 90 days (Heidelberg criteria: hematoma occupying ≥30% of the infarcted area with significant mass effect).
PH2 intracranial hemorrhage within 90 days (Heidelberg criteria: hematoma occupying ≥30% of the infarcted area with significant mass effect).
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