Evaluating HRS8179 for treating severe brain swelling after a major 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 clinical trial aims to assess the efficacy and safety of HRS8179 injection in preventing and treating severe cerebral edema that occurs following a large hemispheric infarction. Participants diagnosed with acute ischemic stroke in the middle cerebral artery territory and exhibiting significant neurological impairment will receive either the HRS8179 treatment or a blank preparation. The study will monitor outcomes related to brain swelling and overall patient recovery. The trial is designed to gather data that could inform future treatment protocols for severe stroke complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);
2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
4. A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
5. The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.

Exclusion Criteria:

1. Theparticipant is likely to withdraw the supportive treatment on the first day;
2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of \>2 mm; CT/MRI indicates cerebral hemorrhage;

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yu Gao
• Email: yu.gao.yg5@hengrui.com
• Phone: 0518-82342973

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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.