Tenecteplase Clot-Dissolving Drug Tested in Stroke Patients Taking Blood Thinners

Trial details

Who runs it

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

Trial code

NCT07092709

Record updated

16 December 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Age 18 years or older; Clinically diagnosed with acute ischemic stroke; DOACs intake within 48 hours prior to enrollment, or on an ongoing DOACs therapy but the exact time of last intake is unknown; To ensure a representative study population, the investigators will limit the number of patients who took DOACs within 24-48 hours before enrollment or those with unknown last intake time to 50% of the planned sample size. If this number is reached, the inclusion criterion 3 will be modified:; DOACs intake within 24 hours prior to enrollment; Study intervention (IVT or placebo) can be started; within 4.5 hours of last known well (LKW). OR; within 4.5 to 24 hours of LKW (including wake-up stroke) AND evidence of target mismatch profile on CT perfusion or MR perfusion (ischemic core volume < 50mL, hypoperfused volume to ischemic core volume ratio > 1.6, mismatch volume ≥10ml); Hypoperfused tissue is defined as Tmax >6s on CT perfusion or MR perfusion. Ischemic core is defined as rCBF <30% on CT perfusion or ADC<620μm\^2/s on diffusion MRI; Baseline National Institutes of Health Stroke Scale (NIHSS) 4-25. OR Disabling stroke with baseline NIHSS of 0-3, including complete hemianopia, aphasia, measurable deficit on motor power, or other disabling neurological deficit judged by the investigator; Written informed consent signed by patients or their legally authorized representatives.

Exclusion: Currently on dual antiplatelet therapy in addition to DOAC therapy; Intracranial surgery, intraspinal surgery or other major surgeries within 3 months before enrollment (based on the assessment of the investigators); Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment; Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history; Allergic to tenecteplase; Pre-stroke mRS≥2; Gastrointestinal or urinary system hemorrhage within the past 3 weeks; Active visceral bleeding; Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management; Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness; Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder; Platelet count less than 100 × 10\^9 /L; Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening; Planned endovascular treatment; Planned DOAC reversal treatment (including Idarucizumab, Andexanet and tranexamic acid); Hypodensity on non-contrast CT estimates to be ≥ 1/3 MCA territory; Severe head trauma or other severe trauma in the last 3 months; Intracranial tumor, arteriovenous malformation and large-size aneurysm (≥10 mm) found before enrollment; Aortic arch dissection confirmed by examination or medical history; Infective endocarditis confirmed by examination or medical history; Pregnant or lactating women; Participating in other trials.

ClinicalTrials.gov NCT07092709