The primary purpose of this trial is to evaluate the effects of Human Urinary Kallidinogenase on improvement of neurological outcome, and early cerebral perfusion in acute ischemic stroke.
This is a multicentre, randomized, open label, blinded-endpoint trial that aims to investigate the effects of Human Urinary Kallidinogenase treatment on neurological outcomes, early cerebral perfusion in patients with acute anterior circulation ischemic stroke. Patients in intervention group will be given 0.15 peptide nucleic acids (PNA) Human Urinary Kallidinogenase concentrated solution for intravenous injection once a day for 10 days continuously, and those in the control group will be given conventional therapy. Both groups of patients will be on standard stroke care. In this study, patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio after the informed consent form (ICF) was received. The total sample size will be 540. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2. Besides, the investigators aimed to use computed tomography perfusion (CTP) evaluate the differences of ischemic penumbra volume and regional cerebral blood flow (rCBF) before and after treatment between intervention group and control group. Furthermore, this study adopts adaptive design, prospectively stating interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either determination of study success or of the futility to continue further enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
540
Intravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip QD for 10 days.
Conventional therapy of acute ischemic stroke after based on Chinese guidelines
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
Time frame: 90 days
Change of Tmax>6s volume
Change of Tmax\>6s volume on CTP from baseline to 5 days after treatment
Time frame: 5 days
Change of rCBF in Tmax>6s area
Change of rCBF in Tmax\>6s area on CTP from baseline to 5 days after treatment
Time frame: 5 days
Ordinal distribution of modified Rankin Scale (mRS) at day 90
Ordinal distribution of modified Rankin Scale (mRS) at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
Time frame: 90 days
The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90
The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
Time frame: 90 days
Change of National Institute of Health stroke Scale (NIHSS) score at day 5 after treatment.
Change of National Institute of Health stroke Scale (NIHSS) score from baseline to 5 days after treatment. NIHSS ranges from 0 to 42, a low value represents a better outcome.
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Time frame: 5 days
Change of National Institute of Health stroke scale (NIHSS) score at day 10 after treatment.
Change of National Institute of Health stroke scale (NIHSS) score from baseline to 10 days after treatment. NIHSS ranges from 0 to 42, a low value represents a better outcome.
Time frame: 10 days