drugset / Trial / NCT07606807
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenecteplase | Protein / enzyme biologic | 0.25 mg/kg | Intravenous |