Reducing brain swelling in patients with large ischemic stroke using a specialized medication
Reduction of Edema With a Specialized Cocktail for Ultra-early Management in Ischemic Stroke
This study is testing a new medication to see if it can help reduce brain swelling in people who have had a large ischemic stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06863571 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial evaluates the safety and efficacy of a pharmacological cocktail (PPA) designed to reduce cerebral edema in patients suffering from large ischemic stroke. The study will enroll 68 patients with middle cerebral artery territory infarction who are not undergoing decompressive craniectomy. Participants will be randomly assigned to receive either the PPA therapy or standard treatment, with the primary outcome being the reduction of cerebral edema assessed through follow-up imaging at 5-7 days. Secondary outcomes will include functional assessments to evaluate overall patient recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with acute ischemic stroke in the middle cerebral artery territory, with specific infarct volume criteria.
Not a fit: Patients with severe comorbidities, contraindications to PPA medications, or those scheduled for decompressive craniectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with large ischemic strokes by reducing brain swelling and associated complications.
How similar studies have performed: While the approach is based on promising preclinical findings, this specific trial represents a novel application of the pharmacological cocktail in a clinical setting.
Eligibility criteria
Show full inclusion / exclusion 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 for decompressive craniectomy (either not indicated or declined by the patient/family) * Written informed consent obtained from the patient or legally authorized representative Exclusion Criteria: * 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 this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Min Lou, PhD, MD
- Email: loumingxc@vip.sina.com
- Phone: 8613958007213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.