Clinical Trial

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

Study acronym: SIMPLIFIED
Recruiting Phase 3
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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).
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-16
Trial Details
NCT Number NCT07606807
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Acute Ischemic Stroke
Enrollment 750 participants
Start Date 2026-08-01
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-15