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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of University of Science and Technology of China

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or greater

Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke).

Prestroke mRS 0-2

NIHSS 6 to 25

Disqualifiers

Current or past history of significant bleeding over the past 6 months;

History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage;

Known bleeding tendency;

Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease;

Trial design

Treatments tested in this trial

  • TNK
  • Standard medical treatment

Treatment groups

794 Participants
are divided into 2 treatment groups