NCT06863571RecruitingPhase 3
Reduction of Edema With a Specialized Cocktail for Ultra-early Management in Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 12 Apr 2025
- Primary completion date
- 10 Mar 2026
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Stroke
- NCT number
- NCT06863571
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 68
- From 12 Apr 2025 to the primary completion date, 10 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to PPA medications (terazosin, urapidil, esmolol, propranolol), such as asthma or severe bradycardia
Other illness
- Severe comorbidities that may interfere with efficacy assessment or safety monitoring (e.g., end-stage organ failure, advanced malignancy)
Other
- Baseline evidence of brain herniation or severe hypotension (SBP \<90 mmHg)
- Pregnancy or lactation
- Participation in another interventional trial that may influence study outcomes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.