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

NCT ID: NCT07253181

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2028-03-30

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 a endovascular capable center (ECC) for endovascular treatment (EVT).

• Primary objective: To evaluate the efficacy of Tenecteplase administration at a nECC before EVT transfer compared with direct transfer on 90-day function outcomes;
• Secondary objective and further: To evaluate the safety of Tenecteplase administration at a nECC before EVT transfer; 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) administered before transfer or direct transfer to ECCs. A single bolus dose should be injected over 5 seconds.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Transportation of Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tenecteplase at a nECC before EVT transfer

Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg. Transport to ECCs for EVT should be initiated as early as possible after administration.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Tenecteplase at a nECC before EVT transfer

Direct transfer

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Tenecteplase at a nECC before EVT transfer

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age of 18 years or older;
• AIS symptom onset 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;
• Written informed consent from patients or legally authorized representatives;
• Neuroimaging:

• ICA or M1, M2 occlusion by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) and ANY of the following:

1. if CT perfusion (CTP) or MR perfusion (MRP) is performed, target mismatch is defined as ischemic core volume <70mL, mismatch volume ≥15mL and mismatch ratio ≥1.8;

2. if CTP or MRP is technically inadequate, an ASPECTS score should be of 7 or more evidenced by CT or MRI scan;

Exclusion Criteria

• Known hypersensitivity or allergy to any ingredients of Tenecteplase;
• 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 estimated to be >1/3 MCA territory, or significant hypodensity outside the Tmax>6s perfusion lesion that invalidates mismatch criteria;
• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim (China) Investment Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junwei Hao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Gaoting Ma, MD

Role: CONTACT

demo_doctor@163.com

+8683198082

Facility Contacts

Gaoting Ma, MD

Role: primary

demo_doctor@163.com

+8683198082

Other Identifiers

[2025]372-001

Identifier Type: -

Identifier Source: org_study_id