Tests tenecteplase for stroke 4.5 to 24 hours after onset, using simple CT
Tests tenecteplase in adults with ischemic stroke, chosen by plain CT scan.
Plain-language title generated from the registry record
Registry title: rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Where in China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Trial code
- NCT07606807
- Record updated
- 15 June 2026
- Original description
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).Read full original descriptionShow less
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
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).
Inclusion: 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: Intracranial or intraspinal surgery within 3 months before enrollment; Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment; 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; Pre-stroke mRS≥2; Allergy to the test drug and its ingredients; Severe head trauma or ischemic stroke in the last 3 months; Gastrointestinal or urinary system hemorrhage within the past 3 weeks; Active visceral bleeding; 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; 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; Platelet count less than 100 × 109 /L; Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening; Endovascular thrombectomy (EVT) planned at the time of randomization; Intracranial tumor or large-size aneurysm found before enrollment; Aortic arch dissection confirmed by examination or medical history; Infective endocarditis confirmed by examination or medical history; Pregnant or lactating women; Participating in other trials.