Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for Reperfusion Therapy.

Starting soon · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

This is a single-center, dose-escalation and dose-expansion Phase I study designed to evaluate the safety of hibernation-like therapy (Chlorpromazine and Promethazine, C+P) and observe improvements in infarct volume in patients with AIS eligible for reperfusion therapy.

Key facts

Study ID

NCT07364344

Run by

Ji Xunming,MD,PhD

People needed

57

Starts

2026-01-01

Expected to finish

2026-07-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Note: The NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficits. Classification:
• *0-1: Normal or near-normal.*
• *1-4: Minor stroke.*
• *5-15: Moderate stroke.*
• *15-20: Moderate to severe stroke.*
• *21-42: Severe stroke.*
• Time from stroke onset to planned drug administration is within 24 hours.
• Pre-stroke modified Rankin Scale (mRS) score of 0 or 1.
• Expected survival greater than 90 days.
• Imaging Inclusion Criteria:
• Pre-procedural angiographic evaluation (NCCT + CTA + CTP / DSA) confirms a large vessel occlusion (internal carotid artery or M1 segment of middle cerebral artery) consistent with clinical symptoms.
• Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6.
• Perfusion-core mismatch: Ischemic core volume 5-70 mL, with a mismatch ratio (volume of hypoperfused tissue / volume of ischemic core) ≥ 1.8 and a mismatch volume ≥ 15 mL.
• Adequate organ function at screening, defined as:
• Platelet count > 100 × 10⁹/L.
• Liver and renal function: ALT/AST ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN; Creatinine clearance (Ccr) > 60 mL/min.
• Female subjects of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative pregnancy test is required within 7 days prior to enrollment. All subjects (male or female) must employ adequate contraceptive measures throughout the treatment period and for 6 months thereafter. (A negative pregnancy test result is mandatory for women of childbearing potential before enrollment).

You may not qualify if…

• 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.
• Conditions contraindicating phenothiazine use at screening, such as Parkinson's disease, parkinsonism, basal ganglia disorders, bone marrow suppression, glaucoma, epilepsy, history of neuroleptic malignant syndrome, or history of hypersensitivity to phenothiazines.
• History of severe infusion reactions deemed ineligible for inclusion upon evaluation.
• History of allergy or anaphylactic shock to iodinated contrast agents.
• Major surgery within 4 weeks prior to drug administration.
• Blood glucose <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L) prior to drug administration (fingerstick glucose results acceptable).
• History of deep vein thrombosis within 6 months prior to drug administration.
• Previous endovascular thrombectomy performed less than 3 months prior.
• Clinically significant active bleeding (e.g., gastrointestinal or other) within 30 days prior to drug administration; coagulation factor abnormalities or bleeding tendency (e.g., on anticoagulants with INR ≥3 or PT ≥3×ULN). However, subjects may be enrolled without awaiting coagulation results if the investigator deems no coagulation dysfunction. Active infection requiring systemic therapy within 2 weeks prior to drug administration (e.g., active tuberculosis).
• Clinically significant cardiac disease at screening, including but not limited to:
• Uncontrolled hypertension (SBP >180 mmHg or DBP >105 mmHg after standard treatment) or hypotension (SBP ≤100 mmHg after standard treatment).
• Unstable angina, myocardial infarction, or coronary artery bypass graft/stent placement within 6 months prior to drug administration.
• History of chronic heart failure (NYHA Class 3-4), or valvular heart disease, deemed ineligible by the investigator.
• Severe arrhythmia requiring treatment or presence of QT interval prolongation at screening, deemed ineligible by the investigator.
• Severe systemic disease at screening deemed ineligible by the investigator, including but not limited to: pulmonary embolism, pulmonary hypertension, severe COPD, active tuberculosis, severe pneumonia, pneumothorax, severe atelectasis, severe pulmonary fibrosis, bronchopulmonary dysplasia, unstable pleural effusion, acute respiratory distress syndrome, irregular breathing patterns or other severe pulmonary diseases; severe hepatic or renal insufficiency such as cirrhosis, hepatic encephalopathy, ascites, obstructive jaundice, renal failure, or uremia.
• Pregnant or lactating women.
• Participation in an interventional clinical trial involving investigational drugs or medical devices within 28 days prior to screening.
• Subjects considered inappropriate for inclusion by the investigator.
• Imaging Exclusion Criteria:
• CTA+CTP/DSA demonstrates excessive vascular tortuosity that may impede delivery of interventional devices.
• Suspected cerebral vasculitis based on history and NCCT+CTA+CTP/DSA findings.
• Suspected aortic dissection based on history and NCCT+CTA+CTP/DSA findings.

Full record on ClinicalTrials.gov

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