A Phase 3 interventional study of Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in Acute Ischemic Stroke, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 3, Interventional, and Treatment
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).
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study with a target enrollment of at least 750 patients. The trial focuses on individuals with acute ischemic stroke (AIS) presenting within a 4.5 to 24-hour window who are not planned for endovascular thrombectomy (EVT). Patients meeting simplified imaging criteria based on non-contrast CT (NCCT) are randomized 1:1 to receive a single intravenous bolus of 0.25 mg/kg tenecteplase (TNK) or standard medical treatment. The primary outcome is the 90-day excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1. Safety outcomes include symptomatic intracranial hemorrhage (sICH) and 90-day mortality.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 750 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous tenecteplase
Drug: Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
Standard medical treatment
Drug: Standard medical treatment
Patients randomized to the intervention arm will receive tenecteplase via a single intravenous bolus (0.25 mg/kg; maximum dose 25 mg), administered immediately following randomization.
Patients in the control arm will receive standard medical treatment.
Excellent functional outcome
The proportion of mRS score 0-1 at 90 (±14) days.
Time frame: at 90 (±14) days
Ordinal distribution of mRS
The proportion of mRS distribution at 90 (±14) days
Time frame: at 90 (±14) days
Favorable functional outcome
The proportion of mRS score 0-2 at 90 (±14) days
Time frame: at 90 (±14) days
Change in NIHSS Score at 24 (±12) hours
NIHSS score change from baseline at 24 (±12) hours
Time frame: at 24 (±12) hours
Change in NIHSS Score at 7 (±1) days or discharge
NIHSS score change from baseline at 7 (±1) days or discharge
Time frame: at 7 (±1) days or discharge
Quality of life (EQ-5D-5L)
Quality of life measured by EQ-5D-5L at 90 (±14) days
Time frame: at 90 (±14) days
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage (sICH) within 36 hours from randomization (SITS-MOST criteria)
Time frame: within 36 hours
Any intracranial hemorrhage
Any intracranial hemorrhage within 36 hours
Time frame: within 36 hours
Major extracranial bleeding
Major extracranial bleeding within 36 hours (GUSTO criteria: moderate and severe bleeding)
Time frame: within 36 hours
Mortality
All-cause mortality within 90 days
Time frame: within 90 days
Plan to share: Yes — The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University