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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke caused by a blocked blood vessel in the front part of the brain, 4.5 to 24 hours before joining, and whose brain scan shows only limited early damage.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Suspected acute ischemic stroke of the anterior circulation, with symptoms starting 4.5 to 24 hours before enrollment (wake-up and unwitnessed strokes count, using the last time the person was known to be well). NIHSS score of 6-25. Only limited early changes on the non-contrast CT scan.
- Earlier treatment
- No heparin or low-molecular-weight heparin in the 24 hours before enrollment. No thrombectomy (clot removal through a blood vessel) planned at the time of randomization.
Main reasons for not taking part
- Bleeding in the brain on the first CT scan
- Clearly marked dead brain tissue on CT, with little expected benefit
- Thrombectomy planned at randomization
- Severe head injury or stroke in the last 3 months
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.