A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,430
Excellent functional outcome
Proportion of subjects with mRS(0-1) at 90 days.
Time frame: 90 days
Good functional outcome
Proportion of subjects with mRS(0-2) at 90 days.
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.
Time frame: 24 hours,day7
EQ-5D
Quality of life measured by EQ-5D scale.
Time frame: 90 days
Barthel (BI)
Global function of daily living defined as BI ≥ 95 at 90 days.
Time frame: 90 days
Modified Rankin Scale(mRS)
Ordinal distribution of mRS at 90 days.
Time frame: 90 days
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