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Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

NCT07475949 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2026-03-17

No results posted yet for this study

Summary

The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.

Conditions

  • Acute Ischemic Stroke
  • Tenecteplase

Interventions

DRUG

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization.

OTHER

Standard medical treatment

Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

Principal Investigators

  • Yuan Wu, MD, PhD · First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2028-12-31

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 NCT07475949 on ClinicalTrials.gov