Tenecteplase Given Before Hospital Transfer for Stroke Caused by a Large Blocked Artery
Tests tenecteplase before transfer in adults with stroke from a blocked brain artery.
Plain-language title generated from the registry record
Registry title: Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
Key facts
- Where
- Beijing and Weifang, ChinaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a stroke caused by a blocked large artery in the front of the brain, who are being moved to another hospital for clot removal 4.5 to 24 hours after the stroke started.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Stroke starting 4.5 to 24 hours ago, with a blocked large artery (ICA, M1 or proximal M2) in the front of the brain. NIHSS score of 6-25. Brain scan results must meet set limits.
- Earlier treatment
- Before the stroke, the person was independent in daily life (mRS 0-2). The person must not be planned to get standard clot-dissolving treatment through a vein.
- Biomarker or test result
- Brain scan showing the blocked artery (by MRA or CTA) and a target mismatch on perfusion scan: core volume under 70mL, mismatch volume of at least 15mL, mismatch ratio of at least 1.8. If no perfusion scan is possible, ASPECTS of 7 or more.
Main reasons for not taking part
- Allergy to any ingredient of Tenecteplase
- Bleeding disorder, or blood-clotting problems from illness or blood thinners
- Stroke, heart attack or brain bleeding in the past 3 months
- Blood pressure above 180/110 mmHg that is not controlled
- Serious illness with life expectancy under 6 months
Read by machine on 9 November 2026.
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Affiliated Hospital of Shandong Second Medical UniversityWeifang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT07253181
- Record updated
- 19 August 2026
- Original description
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).Read full original descriptionShow less
Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours
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.
Inclusion: 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: Intended to receive IVT as standard-of-care therapy; Ischemic stroke or myocardial infarction in previous 3 months; Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months; Current participation in another investigational drug or device study; Known hypersensitivity or allergy to any ingredients of Tenecteplase; 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; Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation; 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; 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; Baseline blood glucose <50mg/dl or >400mg/dl; 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; 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; Suspected endocarditis.