The trial is a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
The study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE), controlled phase 3 trial (2 arms with 1:1 randomization) in ischemic stroke due to anterior circulation large vessel occlusion with perfusion mismatch up to 24 hours of symptom onset. The target mismatch profiles on CTP or MRI perfusion weighted imaging include ischemic core volume \<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software. The minimum sample size is 516 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
516
tenecteplase (0.25 mg/kg) is being used.
Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone are being used.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Excellent functional outcome
Proportion of excellent functional outcome defined as an mRS score ≤ 1 at 90 days
Time frame: 90 days
Ordinal distribution of mRS
Ordinal distribution of mRS at 90 days.
Time frame: 90 days
Favorable functional outcome
Proportion of favorable functional outcome defined by an mRS score ≤ 2 point at 90 days
Time frame: 90 days
Clinical response rate at 72 hours
Clinical response rate at 72 hours defined by an improvement on NIHSS score ≥8 points compared with the initial deficit or a score ≤1.
Time frame: 72 hours
The rate of improvement on reperfusion
The rate of improvement on reperfusion at 24 hours (improved by 90% on Tmax\>6s)
Time frame: 24 hours
NIHSS change from baseline
NIHSS change from baseline at 7 days
Time frame: 7 days
Symptomatic intracranial hemorrhage
Proportion of symptomatic intracranial hemorrhage (sICH) within 36 hours (as defined by The European Cooperative Acute Stroke Study III criteria \[ECASSIII\])
Time frame: 36 hours
Mortality
Rate of death from any cause within 90 days
Time frame: 90 days
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Systemic bleeding
Rate of systemic bleeding at 90 days (as defined by The Global Utilisation of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries \[GUSTO\]: moderate and severe bleeding)
Time frame: 90 days
Adverse events ( AEs ) / serious adverse events ( SAEs )
Rate of adverse events ( AEs ) / serious adverse events ( SAEs ) within 90 days
Time frame: 90 days