Combining Human Urinary Kallidinogenase with Endovascular Therapy for Acute Ischemic Stroke

Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study

This study is testing if adding a new treatment called Human Urinary Kallidinogenase to standard endovascular therapy can help people who have had a severe stroke caused by a blocked blood vessel.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06211712 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Human Urinary Kallidinogenase when used alongside endovascular therapy in patients suffering from acute ischemic stroke due to large vessel occlusion. It is a prospective, randomized, double-blind, placebo-controlled, multi-center trial involving approximately 120 participants. Patients will be assigned to receive either the experimental treatment or a placebo for a duration of 10 days, with primary efficacy assessed at 90 days post-treatment. Safety evaluations will also be conducted over the same period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute anterior circulation ischemic stroke and are receiving endovascular treatment within 24 hours.

Not a fit: Patients with severe organ dysfunction, coagulation disorders, or contraindications to the treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with acute ischemic stroke.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the treatment of acute ischemic stroke, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
2. Age ≥18 years old.
3. The mRS score was 0-1 before onset.
4. ASPECT score of infarction on emergency CT ≥7.
5. Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
6. Emergency CTP or DWI suggesting infarct core body ≥10 mL and \<100 mL, and low perfusion brain tissue volume/ infarct core volume\> 1.2.
7. Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).

Exclusion Criteria:

1. Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
4. Taking ACEI antihypertensive drugs regularly and could not stop.
5. Participant with major surgery or severe trauma in the past 2 weeks.
6. Poor compliance and cannot fully follow the study protocol.
7. Pregnancy or lactation.

Where this trial is running

Shanghai

• Huashan Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Qiang Dong, M.D. — Huashan Hospital
• Study coordinator: Qiang Dong, M.D.

Conditions Acute Ischemic Stroke