Clinical Trial

Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

Recruiting Phase 4
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Summary
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-08-20; most recent amendment 2025-08-20.
Status change: Not Yet Recruiting → Recruiting 2024-01-31
Trial Details
NCT Number NCT06010628
Lead Sponsor General Hospital of Shenyang Military Region
Conditions Stroke, Ischemic
Enrollment 1,440 participants
Start Date 2024-02-01
Primary Completion 2026-12-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-08-21