Tests kallidinogenase in people with acute ischemic stroke receiving reperfusion treatment
Tests kallidinogenase against placebo in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT06848894
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment
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.
Inclusion: 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: Being already treated with HUK or any drugs containing HUK after onset; Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc; Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan; 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; Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators; Having lethal diseases with a life expectancy < 3 months; Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc; Other conditions that investigators consider he/she is not appropriate to participate in this study; 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); Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record; Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment; Participating in another clinical trial currently.