drugset / Trial / NCT06414499

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

NCT06414499

Phase 3 Recruiting 1386 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.

Timeline

Start
2025-07-09
Primary completion
2026-07-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg
Comparator Clopidogrel Small molecule 300 mg
Subject Tenecteplase Protein / enzyme biologic 0.25 mg/kg Intravenous