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

Study acronym: SIMPLIFIED
StatusRecruiting
PhasePhase 3
Started2026-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
Study Identification, Study Status, Contacts/Locations v1
Recruitment opened
Study sitesdetails revised at 1 of 1 site
2026-05-19
Original filing
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).
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