Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,204
- 试验地点
- 1
- 主要终点
- Proportion of a favorable outcome (mRS 0-2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Having anterior circulation AIS within 24 hours of onset.
- •The NIHSS score at enrollment is 4 to
- •Receiving intravenous recombinant tissue plasminogen activator (rt-PA) or TNK-tPA, or endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
- •Being independent in daily activities (mRS ≤1) before onset.
- •Patients or their legal representatives are able and willing to sign informed consent forms.
排除标准
- •Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan.
- •Being already treated with HUK or any drugs containing HUK after onset.
- •Having an allergy history of HUK or drugs containing HUK, or other drugs and food.
- •Having a history of coagulation dysfunction, systemic bleeding, or thrombocytopenia; having hemorrhagic diseases at the time of enrollment, including cerebral hemorrhage, subarachnoid hemorrhage, epidural or subdural hematoma, gingival bleeding, gastrointestinal bleeding, dermal ecchymosis, etc; taking anticoagulants including warfarin, rivaroxaban, etc.; or taking heparin within 48 hours after stroke onset.
- •Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc.
- •Having chronic liver disease or liver dysfunction, with elevated ALT/AST (>3.0×ULN ); or having kidney dysfunction or receiving dialysis, with elevated serum creatinine (>2.0×ULN).
- •Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators.
- •Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
- •Having lethal diseases with a life expectancy < 3 months.
- •Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record.
- •Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc.
- •Participating in another clinical trial currently.
- •Other conditions that investigators consider he/she is not appropriate to participate in this study.
研究组 & 干预措施
Intervention group
HUK (0.15 PNA) and sodium chloride injection (100ml), once per day
干预措施: Human urinary kallidinogenase (HUK) (Drug)
Control group
placebo (0 PNA) and sodium chloride injection (100ml), once per day
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of a favorable outcome (mRS 0-2)
时间窗: at 90 days
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.
次要结局
- Proportion of a favorable outcome (mRS 0-2)(at 14 days)
- Proportion of an excellent outcome (mRS 0-1)(at 90 days)
- Distribution of mRS score(at 90 days)
- Improvement of NIHSS score(at 14 days)
- Risk of recurrent symptomatic stroke(within 90 days)
- Risk of recurrent symptomatic ischemic stroke(within 90 days)
- Risk of combined vascular events(within 90 days)
- Improvement of EQ-5D-5L(at 90 days)
- Improvement of MOCA(at 90 days)
研究者
yilong Wang
Executive Vice-President
Beijing Tiantan Hospital