rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window (NCT07606807) | Clinical Trial Compass
RecruitingPhase 3
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
China750 participantsStarted 2026-08-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Excellent functional outcome
Timeframe: at 90 (±14) days
Trial details
NCT IDNCT07606807
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. 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.
. Endovascular thrombectomy (EVT) planned at the time of randomization.
. Pre-stroke mRS≥2.
. Allergy to the test drug and its ingredients.
. Severe head trauma or ischemic stroke in the last 3 months.
. Intracranial or intraspinal surgery within 3 months before enrollment.
. Intracranial tumor or large-size aneurysm found before enrollment.