RecruitingPhase 3NCT07092709

Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users

Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users (PEARL-DOAC): A Multicenter, Prospective, Randomized, Double-blinded, Placebo-controlled Trial


Sponsor

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

Enrollment

912 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) for people with acute ischemic stroke. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTenecteplase (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.

DRUGPlacebo

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.


Locations(1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT07092709


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