Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Age ≥18 years.
- Having anterior circulation AIS within 24 hours of onset.
- The NIHSS score at enrollment is 4 to 25.
- 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.
Exclusion Criteria:
- 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.