CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 998 target
Drug / intervention
Y-3 for injection +1 moredrug
Likely dose
Y-3 for injection 40 mgfrom record
Key inclusion· 7
  • Age 18-80 years
  • Acute ischemic stroke with NIHSS 7-20
  • Upper limb and lower limb weakness score ≥2 points
  • Onset within 48 hours
Key exclusion· 17
  • Intracranial hemorrhage on imaging
  • Severe consciousness impairment (NIHSS 1a >1)
  • Transient ischemic attack
  • Uncontrolled hypertension ≥220/120 mmHg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06517173
NCT06517173Phase 3RecruitingUpdate OverdueUpdated 21mo ago · Completion was 18mo ago
Enrollment Stalled
Update Overdue

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Y-3 in Chinese Subjects with Acute Ischemic Stroke

Beijing Tiantan Hospital·interventional·Posted Jul 24, 2024·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating Y-3 for injection and Placebo control group for Acute Ischemic Stroke. Currently recruiting, targeting 998 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This trial aims to evaluate the effectiveness and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 3RecruitingOverdue
20252026
First PostedJul 24, 2024
Enrollment StartJul 24, 2024
Primary CompletionDec 1, 2024
Study CompletionJul 1, 2025
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 1.9 years ago

Interventions

Y-3 for injectiondrug

Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.

Placebo control groupdrug

Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.