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).
Age 18 years or older.
Presumed acute ischemic stroke of the anterior circulation.
Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.
Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
Endovascular thrombectomy (EVT) planned at the time of randomization.
Pre-stroke mRS≥2.
Parallel
Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
DrugPatients 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.
Standard medical treatment
DrugPatients in the control arm will receive standard medical treatment.
Excellent functional outcome
The proportion of mRS score 0-1 at 90 (±14) days.
Ordinal distribution of mRS
The proportion of mRS distribution at 90 (±14) days
Favorable functional outcome
The proportion of mRS score 0-2 at 90 (±14) days
Change in NIHSS Score at 24 (±12) hours
NIHSS score change from baseline 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
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