drugset / Trial / NCT07606807

rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window

NCT07606807

RandomizedParallel-groupSingle-blindTreatment

Summary

The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).

Timeline

Start
2026-08-01
Primary completion
2028-12-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenecteplase Protein / enzyme biologic 0.25 mg/kg Intravenous

Indications