Using Human Urinary Kallidinogenase for treating acute ischemic stroke

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

This study is testing if adding a new treatment called Human Urinary Kallidinogenase can help people with acute ischemic stroke recover better and stay safe while they receive standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1204 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06848894 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of Human Urinary Kallidinogenase (HUK) in patients with acute ischemic stroke who are receiving standard reperfusion treatments such as intravenous thrombolysis or endovascular therapy. Eligible participants will be randomly assigned to receive either HUK or a placebo in addition to their standard treatment within 24 hours of symptom onset. The treatment will be administered daily for 10 to 14 days, with follow-up assessments conducted over a total duration of 90 days to evaluate outcomes. The goal is to determine if HUK can improve recovery and safety in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with anterior circulation acute ischemic stroke who are receiving reperfusion treatment within 24 hours of symptom onset.

Not a fit: Patients with severe pre-existing brain damage or those who have already received HUK treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While the use of HUK in this context is novel, similar studies exploring adjunctive therapies for acute ischemic stroke have shown promising results.

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Wang Yilong, MD, PhD

Conditions: Acute Ischemic Stroke, Human Urinary Kallidinogenase, Reperfusion Treatment