NCT07168278

Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT

Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 794 (estimated)
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:\* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .\* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.\* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.

Conditions

• Acute Ischemic Stroke
• Large Vessel Occlusion
• Tenecteplase
• Thrombolysis

Interventions

Type	Name	Description
DRUG	TNK	a dose of 0.25 mg/kg (max 25 mg) administered as a bolus
DRUG	Standard medical treatment	antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-03-01
• Completion: 2028-05-31
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China