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

Recruiting now · Phase 3

Conditions studied: Ischemic Stroke

In brief

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 will be randomized to receive PPA therapy or standard treatment. The primary outcome is cerebral edema at 5-7 days, with secondary outcomes including 90-day functional outcomes (mRS) and safety assessments.

Key facts

Study ID

NCT06863571

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

68

Starts

2025-04-12

Expected to finish

2026-06-30

Last updated by the study team

2025-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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