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Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users

NCT07092709 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 912

Last updated 2025-12-16

No results posted yet for this study

Summary

An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome.

Conditions

  • Acute Ischemic Stroke

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, and within 24 hours of stroke onset.

DRUG

Placebo

Matched placebo 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, and within 24 hours of stroke onset.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Yamei Tang · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Raul G. Nogueira · UPMC Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2028-09-01
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07092709 on ClinicalTrials.gov