Recruiting

Specialized Cocktail for Cerebral Edema in Large Ischemic Stroke

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What is being tested

PPA Intervention

Drug
Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactMin Lou, PhD, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 12, 2025

Actual date on which the first participant was enrolled.

Large ischemic stroke is a serious condition that can lead to significant brain swelling and pressure inside the skull, often resulting in poor recovery. Current treatments sometimes fail to prevent this swelling, even when procedures to restore blood flow are successful. This study aims to test a new combination of medicines, referred to as PPA, which might reduce brain swelling by balancing certain chemicals in the brain and improving fluid drainage. The study focuses on patients who have experienced a large stroke affecting the middle cerebral artery and are not undergoing surgery to relieve pressure. The hope is to find a better way to manage swelling and improve recovery for these patients. Participants in the study will be split into two groups: one will receive the PPA treatment while the other will receive standard care. The PPA treatment involves a specific regimen of drugs administered over five days, with careful monitoring of blood pressure. The main focus is to see if the new treatment reduces brain swelling within a week, checked through imaging. Researchers will also look at how patients are doing three months later in terms of their overall recovery. Safety is a priority, and any side effects, such as low blood pressure, will be monitored. Patients or their representatives will provide consent to join the study, ensuring ethical standards are met.

Official TitleReduction of Edema With a Specialized Cocktail for Ultra-early Management in Ischemic Stroke
NCT06863571
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactMin Lou, PhD, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

6 inclusion criteria required to participate
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

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5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, ChinaOpen Second Affiliated Hospital of Zhejiang University, School of Medicine in Google Maps
Recruiting
One Study Center