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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT06848894

Run by

Beijing Tiantan Hospital

People needed

1204

Starts

2025-03-01

Expected to finish

2027-12-01

Last updated by the study team

2025-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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