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Reduction of Edema With a Specialized Cocktail for Ultra-early Management in Ischemic Stroke

RecruitingPhase 3Ages 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT06863571 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Large ischemic stroke is a severe subtype of acute ischemic stroke (AIS), often leading to malignant cerebral edema, elevated intracranial pressure, and poor functional outcomes. Despite early aggressive treatment, malignant cerebral edema remains a major determinant of prognosis, even in cases of successful recanalization. Preclinical studies suggest that a pharmacological cocktail (PPA) may alleviate cerebral edema by modulating extracellular potassium balance, maintaining aquaporin-4 expression, and enhancing lymphatic drainage. This multicenter, randomized controlled trial (RCT) aims to assess the safety and efficacy of PPA in reducing cerebral edema and improving outcomes in patients with large ischemic stroke. The study will enroll 68 patients with MCA-territory infarction (80-300 mL infarct volume or ASPECTS 1-5), who are not undergoing decompressive craniectomy. Participants wil

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📋 Eligibility rules (as published)
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
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What it tests

  • PPA Intervention
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Where

1 site
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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