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The Safety and effiCacy of HIbernation-Like Therapy Combining recanaLization in Ischemic Stroke: a Phase 1, Dose-escalation Study (CHILL-1)
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.
Details
| Lead sponsor | Capital Medical University |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 32 |
| Start date | 2024-11-09 |
| Completion | 2025-02 |
Conditions
- Acute Ischemic Stroke
Interventions
- chlorpromazine and promethazine
- Placebo group
- endovascular thrombectomy
- rt-PA
Primary outcomes
- The incidence and severity of all adverse events (AEs) and severe adverse events (SAEs) — 72 hours after randomization
AEs including: 1. Severe hypothermia with body temperature\<32 degree centigrade 2. Severe hypotension with systolic blood pressure\<90mmHg that needs additional support 3. Any forms of intracranial hemorrhage 4. Coma 5. Death within 72h 6. Respiratory depression defined as respiration rate\<8 bpm/min 7. Extrapyramidal symptoms including Parkinsonism, dystonia, dyskinesia. AEs are defined as severe adverse events(SAEs) if severity reaches grade 3-5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ver. 5.0.
Countries
China