This study aims to explore the efficacy and safety of Human Urinary Kallidinogenase for acute ischemic stroke patients receiving intravenous thrombolysis and/or endovascular treatment.
Within 24 hours after symptom onset, eligible participants will be randomly assigned in a 1:1 ratio to the HUK or placebo group, receiving adjunctive HUK or placebo treatment alongside standard intravenous thrombolysis and/or endovascular treatment. All participants will be recommended to continuously inject drugs or placebo for 10 to 14 days according to length of hospitalization. * Intervention group: HUK (0.15 PNA) and sodium chloride injection (100ml), once per day * Control group: placebo (0 PNA) and sodium chloride injection (100ml), once per day The total follow-up duration is 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,204
HUK (0.15 PNA) and sodium chloride injection (100ml), once per day
placebo (0 PNA) and sodium chloride injection (100ml), once per day
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Proportion of a favorable outcome (mRS 0-2)
The proportion of a favorable outcome, defined by a modified Rankin Scale (mRS) score ranging from 0 to 2, reflects the percentage of patients who attained a functional status from no symptoms to mild disability, enabling them to perform all pre-stroke activities without assistance.
Time frame: at 90 days
Proportion of a favorable outcome (mRS 0-2)
The proportion of a favorable outcome, defined by a modified Rankin Scale (mRS) score ranging from 0 to 2, reflects the percentage of patients who attained a functional status from no symptoms to mild disability, enabling them to perform all pre-stroke activities without assistance.
Time frame: at 14 days
Proportion of an excellent outcome (mRS 0-1)
The proportion of an excellent outcome, characterized by a modified Rankin Scale (mRS) score of 0 to 1, represents the percentage of patients who achieved a functional status from no symptoms to no significant disability despite symptoms, allowing them to resume all pre-stroke activities without any aid.
Time frame: at 90 days
Distribution of mRS score
The distribution of modified Rankin Scale (mRS) scores provides a comprehensive overview of the functional outcomes across a patient population, categorizing the degree of disability from no symptoms (score 0) to severe disability or death (score 6).
Time frame: at 90 days
Improvement of NIHSS score
The improvement of the National Institutes of Health Stroke Scale (NIHSS) score serves as a quantifiable measure of neurological recovery, reflecting the reduction in stroke-related deficits and the enhancement of patient functional capabilities over time. Minimum Score: 0 (no stroke symptoms) Maximum Score: 42 (severe stroke) Higher NIHSS scores indicate more severe stroke symptoms and are associated with worse outcomes.Lower NIHSS scores indicate milder stroke symptoms and are associated with better outcomes.
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Time frame: at 14 days
Risk of recurrent symptomatic stroke
The risk of recurrent symptomatic stroke quantifies the probability of a subsequent stroke event with clinical manifestations, providing a critical measure for assessing the long-term efficacy of stroke prevention strategies and the ongoing vulnerability of the patient population.
Time frame: within 90 days
Risk of recurrent symptomatic ischemic stroke
The risk of recurrent symptomatic ischemic stroke delineates the likelihood of a subsequent ischemic stroke event accompanied by clinical symptoms, serving as a pivotal indicator for evaluating the effectiveness of secondary prevention measures and the persistent threat of cerebral ischemia in affected individuals.
Time frame: within 90 days
Risk of combined vascular events
The risk of combined vascular events encompasses the probability of experiencing any major vascular incident, such as stroke, myocardial infarction, or vascular death, offering a comprehensive metric for assessing the overall burden of vascular disease and the aggregate impact of therapeutic interventions on cardiovascular health.
Time frame: within 90 days
Improvement of EQ-5D-5L
The improvement of EQ-5D-5L(EuroQol 5-Dimension 5-Level) reflects an enhancement in health-related quality of life, as measured by gains across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-on a five-level severity scale, indicating a positive shift in the patient's overall health state and well-being. Minimum Score: 0 (worst imaginable health state) Maximum Score: 100 (best imaginable health state) For the descriptive system, a lower score (closer to 11111) indicates better health-related quality of life, while a higher score (closer to 55555) indicates worse health-related quality of life. For the VAS, a higher score (closer to 100) indicates better self-rated health, while a lower score (closer to 0) indicates worse self-rated health.
Time frame: at 90 days
Improvement of MOCA
The improvement of the Montreal Cognitive Assessment (MoCA) score signifies an enhancement in cognitive function, encompassing domains such as attention, memory, language, and executive functions, thereby indicating a positive progression in the patient's cognitive status and potential recovery from cognitive impairment. Minimum Score: 0 (severe cognitive impairment) Maximum Score: 30 (no cognitive impairment) Higher MoCA scores indicate better cognitive function. Lower MoCA scores indicate worse cognitive function.
Time frame: at 90 days