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Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours

NCT07253181•Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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), MCA (M1 or 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: ICA or M1, M2 occlusion 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):
•The presence of a diffusion-weighted imaging (DWI)-fluid-attenuated inversion recovery (FLAIR) mismatch pattern (i.e., acute ischemic lesion visible on DWI but no marked parenchymal hyperintensity visible on FLAIR) OR 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;
+8 more criteria

Locations (2)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Affiliated Hospital of Shandong Second Medical University

Weifang, Shandong, China

Key Dates

Start Date

January 6, 2026

Primary Completion Date

March 30, 2028

Completion Date

March 30, 2028

Last Updated

March 19, 2026

Enrollment

572

ESTIMATED participants

Conditions

Acute Ischemic StrokeLarge Vessel OcclusionTransportation of Patients

Interventions

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

DRUG

Contacts

Gaoting Ma, MD

CONTACT

+8683198082 demo_doctor@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Inclusion Criteria

Exclusion Criteria

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