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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Second Affiliated Hospital of Zhejiang University, School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Min Lou, PhD, MD
loumingxc@vip.sina.com
8613958007213
Time Frame
Start Date: 2025-04-12
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 68
Treatments
Experimental: PPA Intervention Group
Participants in this group will receive a pharmacological cocktail (PPA) for five days in addition to standard medical treatment for acute ischemic stroke. The regimen includes terazosin or urapidil, and propranolol or esmolol, with individualized blood pressure management. The specific protocol is as follows:~* Terazosin (no less than 1 mg orally or via nasogastric tube, nightly) or Urapidil (100 mg in 30 mL saline, IV infusion at no less than 2 mL/h)~* Propranolol (10 mg orally or via nasogastric tube, three times daily) or Esmolol (1 g in 40 mL saline, IV infusion at no less than 2 mL/h; use for no more than 48 hours. Beyond 48 hours, switch to Propranolol)
No_intervention: Standard Treatment Group
Participants in this group will receive standard medical treatment for acute ischemic stroke without the PPA intervention. This includes appropriate supportive care, blood pressure management according to clinical guidelines, and symptomatic treatment as required.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov