rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
Recruiting
Phase 3Interventional Study
Acute Ischemic Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
750 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
Who this trial is looking for
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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).
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Eligibility Criteria
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 …
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.
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