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

NCT07253181 | Recruiting Phase 3 DMC

• 1 other identifier: [2025]372-001
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Transportation of Patients

Keywords

interhospital transfer; acute ischemic stroke; anterior circulation large vessel occlusion

Outcome Measures

Primary Outcomes (1)

• Level of disability (ordinal mRS score)

  the ordinal score on the modified Rankin scale; The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death).

  at 90 (±7) days

Secondary Outcomes (8)

• Excellent outcome

  at 90 (±7) days

• Functional independence

  at 90 (±7) days

• Ambulatory and self-care capable

  at 90 (±7) days

• Health-related quality of life

  at 90 (±7) days

• Incidence of arterial recanalization

  Day 1

Other Outcomes (3)

• Symptomatic intracranial hemorrhage (sICH)

  within 36 hours

• Parenchymal hematoma type 2 (PH2)

  within 36 hours

• All-cause mortality

  up to 90 (±7) days

Study Arms (2)

Tenecteplase before transfer

EXPERIMENTAL

Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg. Tenecteplase is for IV administration only. A single bolus dose should be administered over 5 seconds based on patient weight. Transport to ECCs or transfer physician for EVT should be initiated as early as possible after administration according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023.

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

Standard of care

NO INTERVENTION

Patients will receive standard treatment and be directly transferred to ECCs or transfer physician for EVT according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023.

Interventions

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

Tenecteplase at a nECC before EVT transfer

Tenecteplase before transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);
• Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation;

Sponsors & Collaborators

• Boehringer Ingelheim (China) Investment Co., Ltd: collaborator
• Xuanwu Hospital, Beijing: lead
• Jeffrey Saver: collaborator
• Thanh N. Nguyen: collaborator
• Pierre Seners: collaborator
• Jens Fiehler: collaborator
• Maarten Lansberg: collaborator
• Raul G. Nogueira: collaborator

Study Sites (2)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Affiliated Hospital of Shandong Second Medical University

Weifang, Shandong, 261031, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Junwei Hao, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaoting Ma, MD

CONTACT

+8683198082; demo_doctor@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each ECC/nECC will designate one or more physician(s) to perform the follow-up evaluation at 24 (±12) hours, 7 (±2) days or discharge if earlier who cannot be involved in care of the subjects and must remain blinded to treatment assignment. Blinded assessors must undergo a standardized training and competency validation before delegated by the site principal investigator (PI). Assessment of the primary outcome on the mRS at 90 (±7) days will be performed by a qualified neurologist via structured telephone interview, blinded to both the allocated and actually received treatment. All telephone interviews will be recorded by audio and formed into follow-up reports, which will then be centrally assessed by two experienced and certified physicians. For cases with disagreement between the two assessors, decisions are made by the third experienced neurologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase Ⅲ, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) clinical trial.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 28, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)