TNK for Acute Ischemic Stroke in the Extended Time Window with Simple Imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PEARL-SIMPLIFIED is a multicenter, prospective, randomized, open-label trial with blinded outcome assessment. It compares intravenous tenecteplase (0.25 mg/kg up to 25 mg) to standard medical care in AIS patients presenting 4.5–24 hours after onset who are not planned for thrombectomy and meet simplified NCCT criteria. The study plans at least 750 participants and uses a 1:1 randomization. The primary endpoint is superb functional outcome at 90 days (mRS 0–1); safety outcomes include symptomatic intracranial hemorrhage and 90-day mortality.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  Guangzhou, China Recruiting

Study contacts

• Principal investigator: Yamei Tang, MD, PhD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Jinyuan Wang
• Email: wangjy257@mail2.sysu.edu.cn
• Phone: 86-18558992193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.