NCT05700097

Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

A Phase II, Randomized, Double-blind, Placebo-controlled, Dose-Finding, Multi-center Study to Assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy.

Detailed description

To evaluate the safety and efficacy of Dengzhanxixin at different doses of 80ml/day, 40 ml/day, or placebo within 24 hours after the onset of ischemic stroke. The primary objective of this study is the proportion of subjects with excellent outcomes defined as mRS (0-1) among the three treatment groups at 90 days.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Dengzhanxixin Injection	Experimental arms for low, and high dose for the standard protocol
DRUG	Placebo injection	placebo control arm for the standard protocol

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: China