Reduction of Edema With a Specialized Cocktail for Ultra-early Management in Ischemic Stroke
Recruiting
Phase 3
Interventional Study
Ischemic Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 68 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
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 alle…
Trial Locations
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Eligibility Criteria
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 f…
Contacts