rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 750
- Locations
- 1
Study Overview
Brief 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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •Limited early ischemic changes on non-contrast CT (NCCT).
- •Written informed consent signed by patients or their legally authorized representatives.
Exclusion Criteria
- •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≥
- •Allergy to the test drug and its ingredients.
- •Severe head trauma or ischemic stroke in the last 3 months.
- •Intracranial or intraspinal surgery within 3 months before enrollment.
- •Intracranial tumor or large-size aneurysm found before enrollment.
- •Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
- •Active visceral bleeding.
- •Aortic arch dissection confirmed by examination or medical history.
- •Infective endocarditis confirmed by examination or medical history.
- •Platelet count less than 100 × 109 /L.
- •Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
- •Pregnant or lactating women.
- •Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening.
- •Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management.
- •Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.
- •Participating in other trials.
- •Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.