Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
NCT07253181 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572
Last updated 2026-03-19
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
Interventions
- DRUG
-
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
Tenecteplase at a nECC before EVT transfer
Sponsors & Collaborators
-
Boehringer Ingelheim (China) Investment Co., Ltd
collaborator UNKNOWN -
Jeffrey Saver
collaborator UNKNOWN -
Maarten Lansberg
collaborator UNKNOWN -
Thanh N. Nguyen
collaborator UNKNOWN -
Pierre Seners
collaborator UNKNOWN -
Jens Fiehler
collaborator UNKNOWN -
Raul G. Nogueira
collaborator UNKNOWN -
Xuanwu Hospital, Beijing
lead OTHER
Principal Investigators
-
Junwei Hao, MD, PhD · Xuanwu Hospital, Beijing
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-06
- Primary Completion
- 2028-03-30
- Completion
- 2028-03-30
Countries
- China
Study Locations
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