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

NCT07168278 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 794

Last updated 2025-09-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of University of Science and Technology of China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-03-01
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168278 on ClinicalTrials.gov