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CHILL-SHibernation-Like Therapy Safety and Efficacy in Acute Ischemic Stroke Patients Undergoing Reperfusion Therapy

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What is being tested

Hibernation-like Therapy (Chlorpromazine and Promethazine, C+P)

Drug
Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 80 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorJi Xunming,MD,PhD
Study Contact琦 王, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This clinical study focuses on the safety and preliminary effectiveness of a unique treatment approach, called Hibernation-Like Therapy, for patients who have experienced an acute ischemic stroke (AIS) and are eligible for reperfusion therapy. This treatment combines two medications, Chlorpromazine and Promethazine (C+P), and is designed to help protect the brain during stroke. The study is important as it aims to find a new way to improve care for stroke patients, potentially reducing damage caused by the stroke and improving recovery. The study is divided into two parts: a dose-escalation phase and a dose-expansion phase. In the dose-escalation phase, the doses of Chlorpromazine and Promethazine will be gradually increased to find the safest and most effective dose. Participants will receive the study drugs through an intravenous infusion, followed by reperfusion therapy. The safety of the treatment will be closely monitored for 3 days after administration. In the dose-expansion phase, more participants will receive the determined safe and effective dose of the study drugs. Throughout the study, participants will undergo ECG monitoring, vital sign checks, and imaging follow-ups to evaluate the safety and effectiveness of the treatment.

Official TitleA Single-Center,Open-Label Clinical Study on the Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for Reperfusion Therapy.
NCT07364344
Principal SponsorJi Xunming,MD,PhD
Study Contact琦 王, Doctor
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

57 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.

From 18 to 80 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

10 inclusion criteria required to participate
The subject or their legal guardian voluntarily agrees to participate by providing written informed consent, and agrees to comply with the trial treatment plan and visit schedule.

Male or female, aged 18 to 80 years (inclusive).

Diagnosis of acute ischemic stroke eligible for endovascular therapy.

Clinical signs and symptoms consistent with acute anterior circulation ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20 (inclusive).

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18 exclusion criteria prevent from participating
Presence of pathological fever at screening: axillary temperature ≥ 37.3°C or tympanic membrane temperature ≥ 37.9°C.

Clinical presentation suggestive of intracranial parenchymal hemorrhage or subarachnoid hemorrhage (even with normal imaging findings).

Stroke onset accompanied by seizures at screening, precluding accurate NIHSS assessment.

Coma or psychiatric disorders at screening that interfere with neurological evaluation.

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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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

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.
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