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.
18 to 80 years of age;
Diagnosis of anterior circulation acute ischemic stroke;
Within 48 hours of symptoms onset;
modified Rankin Scale (mRS) score≤1 before this event;
Patients who have already or are going to receive intravenous thrombolytic/mechanical thrombectomy therapy after onset;
Patients with severe consciousness disorder, NIHSS 1a consciousness level score≥2;
Patients with limited limb mobility such as fractures and claudication upon admission;
Patients who have already or are going to receive Edaravone injection, Edaravone and DeKanol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules after onset;
Parallel
Human Urinary Kallidinogenase
DrugIntravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip QD for 10 days.
Clinical Routine Treatment
Other interventionConventional 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.
Change of Tmax>6s volume
Change of Tmax\>6s volume on CTP from baseline to 5 days after treatment
Change of rCBF in Tmax>6s area
Change of rCBF in Tmax\>6s area on CTP from baseline to 5 days after treatment
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.
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.
Change of regional cerebral blood volume (rCBV) in Tmax>6s area
Change of regional cerebral blood volume (rCBV) in Tmax\>6s area on CTP from baseline to 5 days after treatment
Change of mean transit time (MTT) in Tmax>6s area
Change of mean transit time (MTT) in Tmax\>6s area on CTP from baseline to 5 days after treatment
Change of Tmax>4s volume
Change of Tmax\>4s volume on CTP from baseline to 5 days after treatment
Change of Tmax>8s volume
Change of Tmax\>8s volume on CTP from baseline to 5 days after treatment
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Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Peking University People's Hospital
Collaborator
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