Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06863571

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-04-18

68

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6518 years
  • Clinical diagnosis of acute ischemic stroke 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
Not Eligible

You will not qualify if you...

  • Baseline evidence of brain herniation or severe hypotension (systolic blood pressure <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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

M

Min Lou, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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