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

Официальное название

rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
  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.
• Препарат Standard medical treatment
  Patients in the control arm will receive standard medical treatment.

Первичные конечные точки

• Excellent functional outcome [Срок оценки: at 90 (±14) days]

Вторичные конечные точки (9)

• Ordinal distribution of mRS [Срок оценки: at 90 (±14) days]
• Favorable functional outcome [Срок оценки: at 90 (±14) days]
• Change in NIHSS Score at 24 (±12) hours [Срок оценки: at 24 (±12) hours]
• Change in NIHSS Score at 7 (±1) days or discharge [Срок оценки: at 7 (±1) days or discharge]
• Quality of life (EQ-5D-5L) [Срок оценки: at 90 (±14) days]
• Symptomatic intracranial hemorrhage [Срок оценки: within 36 hours]
• Any intracranial hemorrhage [Срок оценки: within 36 hours]
• Major extracranial bleeding [Срок оценки: within 36 hours]
• Mortality [Срок оценки: within 90 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07606807 · SYSKY-2026-479-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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