Reducing brain swelling in patients with large ischemic stroke using a specialized medication

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 multicenter, randomized controlled trial evaluates the safety and efficacy of a pharmacological cocktail (PPA) designed to reduce cerebral edema in patients suffering from large ischemic stroke. The study will enroll 68 patients with middle cerebral artery territory infarction who are not undergoing decompressive craniectomy. Participants will be randomly assigned to receive either the PPA therapy or standard treatment, with the primary outcome being the reduction of cerebral edema assessed through follow-up imaging at 5-7 days. Secondary outcomes will include functional assessments to evaluate overall patient recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Clinical diagnosis of acute ischemic stroke (AIS) in the middle cerebral artery (MCA) territory
* Symptom onset within 3 days (≤72 hours) before randomization
* Infarct volume of 80-300 mL or ASPECTS 1-5 involving at least two cortical regions
* Not scheduled for decompressive craniectomy (either not indicated or declined by the patient/family)
* Written informed consent obtained from the patient or legally authorized representative

Exclusion Criteria:

* Baseline evidence of brain herniation or severe hypotension (SBP \<90 mmHg)
* Contraindications to PPA medications (terazosin, urapidil, esmolol, propranolol), such as asthma or severe bradycardia
* Severe comorbidities that may interfere with efficacy assessment or safety monitoring (e.g., end-stage organ failure, advanced malignancy)
* Pregnancy or lactation
* Participation in another interventional trial that may influence study outcomes

Where it's running

• Second Affiliated Hospital of Zhejiang University, School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Min Lou, PhD, MD
• Email: loumingxc@vip.sina.com
• Phone: 8613958007213

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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.