Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 80

Hibernation-like therapy for treating acute ischemic stroke

Official title: The Safety and effiCacy of HIbernation-Like Therapy Combining recanaLization in Ischemic Stroke: a Phase 1, Dose-escalation Study

Run by Capital Medical University · NCT06663631 · Data updated 2026-11-12

This study is testing if a combination of two medications can safely help people who have had a stroke during a specific treatment procedure.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment32 (estimated)
SponsorCapital Medical University
Academic / other
Locations1 site (Linyi, Shandong)
StatusRecruiting
StartedNovember 9, 2024
Main results expectedJanuary 2025
Study endsFebruary 2025
Registry record updatedDecember 20, 2024
Trial IDNCT06663631 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-80 with a confirmed diagnosis of acute ischemic stroke and specific eligibility criteria related to stroke severity and timing.

Probably not a fit

Patients with contraindications for reperfusion therapy or those with severe intracranial hemorrhage will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and preliminary efficacy of chlorpromazine and promethazine (C+P) in patients with acute ischemic stroke (AIS) undergoing endovascular thrombectomy. Participants will receive either C+P or a placebo at the start of the procedure, and their health will be monitored for 72 hours to assess any adverse effects. The study will also determine the optimal dosage of C+P that is safe and potentially effective for treating AIS, comparing outcomes using imaging and functional assessments at 90 days. The trial employs a dose-escalation approach to identify the maximum tolerated dose without significant side effects.

Why it matters

Potential benefit: If successful, this therapy could provide a new neuroprotective treatment option for patients suffering from acute ischemic stroke.

How similar studies have gone: While pre-clinical studies have shown promise for C+P in neuroprotection, this specific approach in AIS patients is novel and has not been extensively tested in prior clinical trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Clinical Inclusion Criteria:

  1. Age between 18-80 years(including the critical value)
  2. Ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 6-20
  3. Time from last known to be well to randomization within 24h
  4. Pre-stroke Modified Rankin Scale scoring 0-1.
  5. With indications of reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy).
  6. Informed consent signed by patients or their legal relatives.
  7. CT angiography (CTA) confirmed large vessel occlusion of anterior circulation
  8. Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6-10.
  9. initial infarct volume on CT perfusion (CTP) lesser than 70ml; a ratio of hypoperfused volume to infarcted volume greater than 1.8; absolute mismatch volume greater than 15 ml according to DEFUSE-3 trial.

Exclusion Criteria:

* Clinical Exclusion Criteria:

  1. Clinical findings suggest intracranial parenchymal hemorrhage or subarachnoid hemorrhage.
  2. Accompanied by epilepsy.
  3. Accompanied by coma or mental disorders, may interfere with neurological function assessment.
  4. History of premorbid phenothiazine allergy or contraindication.
  5. History of allergy to iodine contrast medium or anaphylactic shock
  6. Baseline blood glucose \<50mg/dL (2.78mmol) or \>400mg/dL (22.20mmol)

     \* Acceptable fingertip blood glucose results
  7. Baseline platelet \<50×109 /L
  8. Recent (i.e. within 30 days prior to randomization) history of gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal clotting factors, or bleeding tendency (INR≥3 or PT≥3×ULN on anticoagulants; If the investigator believes that the subject does not have coagulation dysfunction, it is not necessary to wait for the results of the coagulation test before deciding whether to enroll.)
  9. The stroke is accompanied by fever, or there is an active infection requiring systemic treatment (such as active tuberculosis, etc.)
  10. Expected survival less than 90 days (According to the Chinese Guidelines for Early Endovascular Interventional Diagnosis and Treatment of Acute Ischemic Stroke 2022, expected survival less than 90 days is a contraindication for endovascular therapy)
  11. A history of severe cardiovascular disease, including but not limited to: uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg after standard treatment), hypotension (systolic blood pressure ≤100 mmHg after standard treatment), or pulmonary hypertension; Had unstable angina pectoris, myocardial infarction, or bypass or stent surgery within 6 months before randomization; New York Heart Association (NYHA) grade 3-4 history of chronic heart failure; Clinically significant valvular disease; Severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), including QT interval ≥450ms for men and ≥470ms for women
  12. accompanied by chronic obstructive pulmonary disease(COPD), tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, respiratory irregularity and other lung diseases
  13. Severe hepatic and renal insufficiency, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr\<25ml/min), hepatorenal syndrome, etc
  14. Pregnancy or lactating women
  15. Participation in other clinical trials and have used an investigational drug or medical device
  16. Patients that may not be able to complete the study for other reasons or who the investigator believes should not be included
* Image exclusion criteria:

  1. computed tomographic angiography(CTA)/magnetic resonance angiography(MRA)/digital substraction angiography(DSA) shows excessive vascular curvature, which may hinder delivery of interventional devices
  2. Cerebrovascular inflammation is suspected based on medical history and CTA/MRA/DSA
  3. Aortic dissection is suspected based on medical history and CTA/MRA/DSA
  4. CTA/MRA/DSA confirmed multi-vascular regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of bilateral or multi-regional infarction
  5. CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome
  6. CT/MRI confirmed a significant midline shift effect
  7. CT/MRI confirms the presence of intracranial tumors (except cerebellar meningioma) CT/MRI confirmed intracranial hemorrhage

Where it's running

  • Linyi People's Hospital
    Linyi, Shandong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.