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.
Standard medical treatment: Patients in the control arm will receive standard medical treatment.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age 18 years or older.
2. Presumed acute ischemic stroke of the anterior circulation.
3. 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'.
4. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
5. Limited early ischemic changes on non-contrast CT (NCCT).
6. Written informed consent signed by patients or their legally authorized representatives.
Exclusion Criteria:
1. Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
2. Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
3. Endovascular thrombectomy (EVT) planned at the time of randomization.
4. Pre-stroke mRS≥2.
5. Allergy to the test drug and its ingredients.
6. Severe head trauma or ischemic stroke in the last 3 months.
7. Intracranial or intraspinal surgery within 3 months before enrollment.
8. Intracranial tumor or large-size aneurysm found before enrollment.
9. Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
10. Active visceral bleeding.
11. Aortic arch dissection confirmed by examination or medical history.
12. Infective endocarditis confirmed by examination or medical history.
13. Platelet count less than 100 × 109 /L.
14. Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
15. Pregnant or lactating women.
16. Blood glucose \<50 mg/dl (2.78mmol/L) or \>400 mg/dl (22.2mmol/L) during screening.
17. Uncontrolled hypertension with persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to medical management.
18. Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.
19. Participating in other trials.
20. 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.
Primary outcome measure(s)
Excellent functional outcome — at 90 (±14) days The proportion of mRS score 0-1 at 90 (±14) days.
Trial sites (1)
Facility
City
Region
Status
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou
China
Recruiting
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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