The Safety and effiCacy of HIbernation-Like Therapy Combining recanaLization in Ischemic Stroke: a Phase 1, Dose-escalation Study
The goal of this clinical trial is to learn whether chlorpromazine and promethazine（C+P）is safe in Acute Ischemic Stroke（AIS) patients and determine the maximum dosage. It will also evaluate the preliminary efficacy of C+P in AIS. The main questions it aims to answer are: What is the optimal dosage of C+P that is safe without causing adverse effects in AIS patients? What is the optimal dosage of C+P that potentially works to treat AIS? Researchers will compare C+P with placebo (saline solution without C+P) to see if C+P is safe and effective in treating Acute Ischemic Stroke. Participants will: Receive C+P or placebo at the same time as endovascular thrombectomy begins. Patients will be observed for 72 hours to see if there were any adverse effects related to C+P. Infarct volumes will be evaluated using Computed Tomography. Functional outcomes will be assessed at 90 days.
• Clinical Inclusion Criteria:
‣ Age between 18-80 years(including the critical value)
⁃ Ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 6-20
⁃ Time from last known to be well to randomization within 24h
⁃ Pre-stroke Modified Rankin Scale scoring 0-1.
⁃ With indications of reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy).
⁃ Informed consent signed by patients or their legal relatives.
⁃ CT angiography (CTA) confirmed large vessel occlusion of anterior circulation
⁃ Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6-10.
⁃ 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.