To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.
To evaluate the safety and efficacy of rhTNK-tPA at different doses of 0.10 mg/kg, 0.25 mg/kg and 0.32 mg/kg compared with standard rt-PA intravenous thrombolytic therapy within 3 hours after onset of ischemic stroke. The primary objective of this study is to evaluate the differences of NIHSS scores among the four treatment groups at 14 days after intravenous thrombolysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with NIHSS 1 or at least 4 on the NIHSS score decreased from the baseline at day14.
Time frame: 14 days
Modified Rankin Scale (mRS)
1. Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 days. 2. Ordinal distribution of mRS and change of proportion of subjects with mRS (0-2) at 90 days.
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS)
Neurological impairment defined as change of NIHSS score at 90 days.
Time frame: 90 days
Barthel(BI)
Global function of daily living defined as BI ≥ 95 at 90 days.
Time frame: 90 days
EQ-5D
Quality of life measured by EQ-5D scale.
Time frame: 90 days
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