Safety and Dose Study of Chlorpromazine and Promethazine with Endovascular Thrombectomy for Acute Ischemic Stroke Phase 1, Randomized Trial

What this Trial Is About

Researchers are evaluating whether chlorpromazine and promethazine (C+P) are safe and potentially effective in treating patients with Acute Ischemic Stroke (AIS). This phase 1, dose-escalation study aims to find the optimal dosage of C+P that can be safely used without causing adverse effects and to assess preliminary efficacy. The study builds on preclinical evidence that C+P may protect the brain by inducing a hibernation-like state, but the best dose and safety profile in AIS patients receiving reperfusion therapy remain unknown. Participants will receive either C+P or a placebo (saline solution) intravenously at the start of endovascular thrombectomy, a procedure to remove blood clots and restore blood flow to the brain. The C+P or placebo infusion will last approximately 12 hours at a set rate. Four dosage groups of C+P (10mg, 20mg, 50mg, and 100mg) will be tested in a dose-escalation design. Eligible patients may also receive intravenous thrombolysis with rt-PA if indicated. The study plans to enroll between 32 and 64 patients depending on safety outcomes. During the study, participants will be closely monitored for 72 hours after randomization to track any adverse events or severe side effects. Brain imaging using computed tomography will assess infarct volumes. Functional outcomes will be evaluated at 90 days after treatment to measure recovery. The main outcome is the incidence and severity of adverse events within 72 hours, helping to determine the safety and appropriate dose of C+P for future studies.

Study on Hibernation-like Therapy Based on Mechanical Thrombectomy