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Recruiting NCT06848894

Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment

Trial Parameters

Condition Acute Ischemic Stroke
Sponsor Beijing Tiantan Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,204
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03
Completion 2026-12
Interventions
Human urinary kallidinogenase (HUK)Placebo

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.

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 tim

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