NCT07094763Recruiting
Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset
Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Trial
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 406 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- Nov 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Diseases
- Stroke
- NCT number
- NCT07094763
What you commit to
- Study type: Interventional
- Planned participants: 406
- From Nov 2025 to the primary completion date, Oct 2027
- 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
- Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
Other illness
- History of intracranial hemorrhage.
- Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 months.
- Active internal bleeding, major surgery, trauma, gastrointestinal/urinary tract bleeding within 3 weeks.
- Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>110 mmHg unresponsive to antihypertensive therapy).
Lab values
- Clinically significant bleeding or coagulopathy, including: Warfarin use with INR \>1.7 or PT \>15 s; Low-molecular-weight heparin within 24 hours; Direct oral anticoagulants within 48 hours; Laboratory abnormalities (e.g., APTT \>40 s).
- Platelet dysfunction or platelet count \<100×10⁹/L.
- Uncontrolled hypoglycemia/hyperglycemia (\<50 mg/dL \[2.8 mmol/L\] or \>400 mg/dL \[22.2 mmol/L\]).
Other
- Contraindication to tenecteplase or its components.
- Acute anterior circulation infarction confirmed by MRI, anterior circulation large vessel occlusion on vascular imaging (CTA/MRA/DSA), or anterior circulation hypoperfusion on perfusion imaging.
- Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
- Non-compressible arterial puncture within 1 week.
- Suspected aortic dissection.
- Pregnancy or lactation.
- A life expectancy of less than three months.
- Participation in other clinical trials within 3 months or ongoing trial enrollment.
- Inability to follow up (e.g., no fixed residence, overseas patients).
- Patient deemed unsuitable for the trial by site investigator.
Who the study is looking for
- Age ≥18 years.
- Meeting at least one of the following criteria: acute posterior circulation ischemic stroke confirmed by MRI; symptomatic stenosis or occlusion of a posterior circulation large vessel on vascular imaging (CTA/MRA/DSA); perfusion imaging demonstrating clinically relevant hypoperfusion in the posterior circulation territory.
- Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time is defined as the midpoint between last known well and symptom detection).
- NIHSS score\>3.
- PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
- Pre-stroke mRS ≤1.
- Signed informed consent by the patient or legally authorized representative.
Age in the registry: 18 years to 100 years · 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 |
|---|---|---|---|
| The First Affiliated Hospital of the University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.