NCT07606807RecruitingPhase 3
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- Aug 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Stroke
- NCT number
- NCT07606807
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 750
- From Aug 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial or intraspinal surgery within 3 months before enrollment.
- Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
Other illness
- 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.
Lab values
- Platelet count less than 100 × 109 /L.
- Blood glucose \<50 mg/dl (2.78mmol/L) or \>400 mg/dl (22.2mmol/L) during screening.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.