Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
NCT06196320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452
Last updated 2025-11-26
Summary
The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion.
Conditions
- Ischemic Stroke, Acute
Interventions
- DRUG
-
Tenecteplase
Intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) within 24 hours ± thrombectomy at treating clinician's discretion
- DRUG
-
Best Practice (which may include intravenous Alteplase)
Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Yongjun Wang, MD · Beijing Tiantan Hospital
-
Bruce Campbell, MD, PhD · University of Melbourne
-
Fana Alemseged, MD, PhD · University of Melbourne
-
Yunyun Xiong, MD, PhD · Beijing Tiantan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-24
- Primary Completion
- 2025-09-11
- Completion
- 2025-09-22
Countries
- China
Study Locations
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