The purpose of this study is to assess the efficacy and safety of recombinant human tissue plasminogen kinase derivatives for injection and alteplase in the treatment of patients with acute ischemic stroke within 4.5 hours.
This study is a multicenter, randomized, blind endpoint and positive drug control study. The study plans to recruit 1412 AIS patients within 4.5 hours of onset. Qualified subjects are assigned to the test drug and control drug alteplase group according to the ratio of 1:1. After receiving thrombolytic drugs, the subjects need to carry out a series of safety and effectiveness tests. The mRS score and Barthel index score visits are carried out on the 90th day (± 7 days) after thrombolysis. After the visit, the subjects can leave the group. In this study, independent blind endpoint evaluators were set up in each research center to evaluate the mRS and Barthel index score 30 and 90 days after thrombolysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,412
18mg/10ml/stick, provided by Angde Biotech
20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.
Functional handicap
Proportion of patients achieving a Modified Rankin Scale score of 0 to 1 on the 90th day after treatment. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0-5. A separate category of 6 is usually added for patients who expire. The higher the score, the more severe the stroke.
Time frame: on the 90th day after treatment
Proportion of Neurological Improvement
The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline at 24 hours and the 7th day after treatment. The National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on level of consciousness, eye movements, integrity of visual fields, facial movements,arm and leg muscle strength, sensation, coordination, language,speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).
Time frame: at 24hours and the 7th day after treatment
Proportion of Long-term Improvement
Proportion of patients achieving a mRS of 0 to 2 on the 90th day after treatment.
Time frame: on the 90th day after treatment
Ordinary distribution of mRS scores
Ordinary distribution of mRS scores on the 90th day after treatment.
Time frame: on the 90th day after treatment
Barthel Index score
Proportion of patients achieving a Barthel Index score ≥95 on the 90th day after treatment. The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, China
Gaozhou People's Hospital
Gaozhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Yue Bei People's Hospital
Shaoguan, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
...and 68 more locations
Time frame: on the 90th day after treatment