Clinical Trial

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

Study acronym: TRACE Ⅳ
Recruiting Phase 3
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Record status
This record was last updated July 24, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-10; most recent amendment 2025-07-20.
Status change: Not Yet Recruiting → Recruiting 2025-07-20
Status change: Recruiting → Not Yet Recruiting 2025-07-03
Trial Details
NCT Number NCT06414499
Lead Sponsor Beijing Tiantan Hospital
Conditions Minor Ischemic Stroke
Enrollment 1,386 participants
Start Date 2025-07-09
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-24