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RECRUITING
NCT06663631
PHASE1

Study on Hibernation-like Therapy Based on Mechanical Thrombectomy

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-11-09

Completion Date

2025-02

Last Updated

2024-12-20

Healthy Volunteers

No

Interventions

DRUG

chlorpromazine and promethazine

C+P were diluted to 50 ml saline solution and delivered intravenously at the beginning of endovascular thrombectomyat a velocity of 4ml/h. The whole period of drug delivery lasts for approximately 12h.

DRUG

Placebo group

50 ml saline solution was set as placebo and delivered intravenously at the beginning of endovascular thrombectomyat a velocity of 4ml/h. The whole period of drug delivery lasts for approximately 12h.

PROCEDURE

endovascular thrombectomy

All patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion.

DRUG

rt-PA

All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion

Locations (1)

Linyi People's Hospital

Linyi, Shandong, China