This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
674
Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.
Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.
Functional handicap
Proportion of patients achieving a Modified Rankin Scale(mRS,which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) of 0 to 1 at 90 days after treatment.
Time frame: 90days
Proportion of Neurological Improvement
Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment.
Time frame: 90 days
Scores of Neurological Improvement
NIHSS changes from baseline at 24 hours after treatment
Time frame: 24 hours
Long-term Change from Baseline
NIHSS, mRS and Barthel Index(which assesses the ability to perform activities of daily living, on a scale that ranges from 0 to 100) changes from baseline on 90 days after treatment.
Time frame: 90 days
Proportion of Long-term Improvement
Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.
Time frame: 90 days
Systemic hemorrhage
Severe systemic hemorrhage
Time frame: 90days
Symptomatic intracerebral hemorrhage
Symptomatic intracerebral hemorrhage (sICH)
Time frame: 90days
Death
Death
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Beijing Luhe Hospital,Capital Medical University
Beijing, Beijing Municipality, China
XuanWu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The First Hospital of Handan
Handan, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshan Gongren Hospital
Tangshan, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
...and 25 more locations
Time frame: 7 days and 90 days
Recurrence
Recurrence of stroke
Time frame: 7 days
Liver function
The incidence of ALT≥3ULN in liver biochemical examination
Time frame: 7 days
Renal function
The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value
Time frame: 7 days