Clinical trial NCT06848894: Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment
Official title: Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Human Urinary Kallidinogenase
Acute Ischemic Stroke
Reperfusion Treatment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 1204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Having anterior circulation AIS within 24 hours of onset.
3. The NIHSS score at enrollment is 4 to 25.
4. 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.
5. Being independent in daily activities (mRS ≤1) before onset.
6. Patients or their legal representatives are able and willing to sign informed consent forms.

Exclusion Criteria:

1. Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan.
2. Being already treated with HUK or any drugs containing HUK after onset.
3. Having an allergy history of HUK or drugs containing HUK, or other drugs and food.
4. 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.
5. Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc.
6. 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).
7. Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators.
8. Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
9. Having lethal diseases with a life expectancy \< 3 months.
10. Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record.
11. Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc.
12. Participating in another clinical trial currently.
13. Other conditions that investigators consider he/she is not appropriate to participate in this study.

Primary outcomes:
measure: Proportion of a favorable outcome (mRS 0-2)
timeFrame: at 90 days
Secondary outcomes:
measure: Proportion of a favorable outcome (mRS 0-2)
timeFrame: at 14 days
measure: Proportion of an excellent outcome (mRS 0-1)
timeFrame: at 90 days
measure: Distribution of mRS score
timeFrame: at 90 days
measure: Improvement of NIHSS score
timeFrame: at 14 days
measure: Risk of recurrent symptomatic stroke
timeFrame: within 90 days
measure: Risk of recurrent symptomatic ischemic stroke
timeFrame: within 90 days
measure: Risk of combined vascular events
timeFrame: within 90 days
measure: Improvement of EQ-5D-5L
timeFrame: at 90 days
measure: Improvement of MOCA
timeFrame: at 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Wang Yilong, MD, PhD
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Wang Tingting, MD
role: STUDY_DIRECTOR
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