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RECRUITING
NCT06010628
PHASE4

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

Sponsor: General Hospital of Shenyang Military Region

View on ClinicalTrials.gov

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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.

Official title: Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1440

Start Date

2024-02-01

Completion Date

2026-12-15

Last Updated

2025-08-21

Healthy Volunteers

No

Interventions

DRUG

Tenecteplase

intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).

Locations (2)

Hui-Sheng Chen

Shenyang, None Selected, China

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China