NCT07253181 Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
| NCT ID | NCT07253181 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 572 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 572 participants in total. It began in 2026-01-06 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.
Eligibility Criteria
Inclusion Criteria: * Age of 18 years or older; * AIS symptom onset to treatment initiation within 4.5 to 24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke); * Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), M1 or proximal M2 vessels; * Functionally independent (mRS 0-2) prior to stroke onset; * Baseline National Institute of Health Stroke Scale (NIHSS) of 6-25; * Intended to transfer to ECCs for EVT (patient transfer), or intended to transfer a neurointerventionalist from the ECC for EVT (physician transfer); * Written informed consent from patients or legally authorized representatives; * Neuroimaging: large vessel occlusion (ICA, M1, proximal M2) by MRA or CTA AND the target mismatch profile on computed tomography perfusion (CTP) or magnetic resonance perfusion (MRP), defined as an ischemic core volume \<70mL, mismatch volume ≥15mL and mismatch ratio ≥1.8; Alternative neuroimaging (if CTP or MRP is technically inadequate or unavailable): An Alberta Stroke Program Early CT Score (ASPECTS) score ≥7 on NCCT or MRI scan; Exclusion Criteria: * Known hypersensitivity or allergy to any ingredients of Tenecteplase; * Intended to receive IVT as standard-of-care therapy; * Rapidly improving symptoms with NIHSS score \<6 before randomization; * Any contra-indication for IVT except for the time criterion; * Known hereditary or acquired hemorrhagic diathesis; * Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, INR \>1.7 or prothrombin time \>15s; if use of any direct oral anticoagulant within the last 48 hours; if on any full dose heparin/heparinoid within the last 24 hours; * Ischemic stroke or myocardial infarction in previous 3 months * Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months; * Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg); * Other serious, advanced or terminal illness with life expectancy less than 6 months; * Baseline blood glucose \<50mg/dl or \>400mg/dl; * Contraindication to imaging with contrast agents; * Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA or MRA (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion); * Extensive early ischemic change on non-contrast CT or MRI-DWI estimated to be \>1/3 MCA territory, or significant hypodensity outside the Tmax\>6s perfusion lesion that invalidates mismatch criteria (if patient is enrolled based on CT perfusion criteria); any CT or MRI findings indicative of a high risk of sICH related to potential intravenous tenecteplase treatment in the judgement of the investigator; * Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation; * Current participation in another investigational drug or device study; * Suspected endocarditis; * Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
Contact & Investigator
Junwei Hao, MD, PhD
PRINCIPAL INVESTIGATOR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT07253181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07253181 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 572 participants.
Is NCT07253181 currently recruiting?
Yes, NCT07253181 is actively recruiting participants. Contact the research team at demo_doctor@163.com for enrollment information.
Where is the NCT07253181 trial being conducted?
This trial is being conducted at Beijing, China, Weifang, China.
Who is sponsoring the NCT07253181 clinical trial?
NCT07253181 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is Junwei Hao, MD, PhD at Xuanwu Hospital, Beijing. The trial plans to enroll 572 participants.
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