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A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke — XY03-EA  

Acute Ischemic Stroke Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Dose-exploration Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke

Clinical Trial Summary

Overall Design: a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-exploration study. Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke.

Clinical Trial Description

The population is patient who with acute ischemic stroke within 48 hours of onset (including RT-PA intravenous thrombolytic therapy) . The patients were randomized based on being received rt-PA Intravenous thrombolysis or not. Patients who met the inclusion criteria for the protocol were stratified randomly and assigned in a 1:1:1 ratio to three groups: the XY03-EA 300mg, 600mg two-dose group, and the placebo group. The study was divided into 3 stages: screening stage, treatment stage and follow-up stage. The sample size was 420 patients. Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke. Secondary outcome: 1. Explore the dose-response relationship of XY03-EA tablets in the treatment of acute ischemic stroke, and provide data support for later clinical study; 2. Explore PK characteristics of XY03-EA and its metabolites in patients with acute ischemic stroke based on population PK analysis method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05515393
Study type Interventional
Source Shijiazhuang Yiling Pharmaceutical Co. Ltd
Contact
Status Enrolling by invitation
Phase Phase 2
Start date September 24, 2022
Completion date December 30, 2023
View Details
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