Combining Human Urinary Kallidinogenase with Endovascular Therapy for Acute Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Huashan Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Qiang Dong, M.D. — Huashan Hospital
• Study coordinator: Qiang Dong, M.D.
• Email: 13701747065@163.com
• Phone: 13701747065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.