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New treatment option for Acute Ischemic Stroke
Official title rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
ClinicalTrials.gov ID: NCT07606807
What this study is testing
What is Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)?
Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
- Limited early ischemic changes on non-contrast CT (NCCT).
You likely can't join if
- Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the...
- 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.
See the full eligibility 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.
- 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.
- Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
- Active visceral bleeding.
- Aortic arch dissection confirmed by examination or medical history.
- Infective endocarditis confirmed by examination or medical history.
- Platelet count less than 100 × 109 /L.
- Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
- Pregnant or lactating women.
- Blood glucose \ 400 mg/dl (22.2mmol/L) during screening.
- 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.
- Participating in other trials.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.