The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.
After being informed about the study and potential risks, patients who meet the eligibility requirements will be randomized to recombinant human Prourokinase for injection (rhPro-UK) or standard medical treatment in a 1:1 ratio. Written informed consent will be needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,446
15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.
Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.
The modified Rankin Scale score (mRS) ≤ 1 at 90 days
The proportion of the modified Rankin Scale score (mRS) ≤ 1 at 90 days.
Time frame: 90 days
Ordinal distribution of mRS at 90 days
Ordinal distribution of mRS at 90 days
Time frame: 90 days
mRS score ≤ 2 at 90 days
The proportion of mRS score ≤ 2 at 90 days
Time frame: 90 days
Early neurological functional improvement
Clinical response rate at 24 hours defined as an improvement on NIHSS score ≥ 4 points compared with the initial deficit or NIHSS score ≤ 1 point
Time frame: 24 hours
Barthel index of 75-100 points at 90 days
The proportion of Barthel index of 75-100 points at 90 days
Time frame: 90 days
Quality of Life (EQ-5D-5L) at 90 days
The value of Quality of Life (EQ-5D-5L) at 90 days
Time frame: 90 days
Activities of Daily Living (Lawton IADL) at 90 days
The score of Activities of Daily Living (Lawton IADL) at 90 days
Time frame: 90 days
Symptomatic intracranial hemorrhage within 36 hours
The rate of symptomatic intracranial hemorrhage within 36 hours (as defined by ECASS III)
Time frame: 36 hours
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Taihe Hospital of Traditional Chinese Medicine
Fuyang, Anhui, China
Lujiang County People's Hospital,Anhui Province
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Hospital of Fangshan District, Beijing
Beijing, Beijing Municipality, China
Chongqing Sanbo Chang 'an Hospital
Chongqing, Chongqing Municipality, China
Dingxi People's Hospital
Dingxi, Gansu, China
Jiuquan City People's Hospital
Jiuquan, Gansu, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Heyuan People's Hospital
Heyuan, Guangdong, China
People's Hospital of Huazhou
Maoming, Guangdong, China
...and 79 more locations
All-cause death at 90 days
All-cause mortality at 90 days
Time frame: 90 days
Systematic bleeding at 90 days
The rate of systematic bleeding at 90 days (as defined by GUSTO: moderate and severe bleeding)
Time frame: 90 days
Adverse events (AEs)/ serious adverse events (SAEs) within 90 days
The proportion of AEs/SAEs within 90 days
Time frame: 90 days