This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
149
Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
Aspirin 300mg is taken orally at the beginning of thrombolysis.
Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
XuanWu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Harrison International Peace Hospital
Hengshui, Hebei, China
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
Index Long-term Change from Baseline of Barthel Index
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
Long-term Change from Baseline of NIHSS
NIHSS changes from baseline on 90 days after treatment.
Time frame: 90 days
Long-term Change from Baseline of mRS
mRS 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 at 90 days after treatment.
Time frame: 90 days
Proportion of Long-term Improvement
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Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.
Tangshan Gongren Hospital
Tangshan, Hebei, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
The Second People'Hospital of Huai'an
Huai'an, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
...and 9 more locations
Proportion of patients achieving 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
Time frame: 7 days and 90 days
Recurrence
Recurrence of stroke
Time frame: 7 days