Tenecteplase Clot-Dissolving Drug Tested in Stroke Patients Taking Blood Thinners
Tests tenecteplase against placebo in adults with stroke after recent blood thinner use.
Plain-language title generated from the registry record
Registry title: Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an acute stroke caused by a blocked blood vessel who recently took a blood thinner by mouth (a DOAC). It tests whether a clot-dissolving drug, tenecteplase, helps recovery at 90 days compared with placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke. Treatment must start within 4.5 hours of last known well, or within 4.5 to 24 hours if brain scans show a target mismatch profile. Stroke severity score (NIHSS) 4-25, or 0-3 if the stroke is disabling.
- Earlier treatment
- Must have taken a DOAC within 48 hours before enrollment, or be on DOAC therapy with the time of the last dose unknown. Cannot have had heparin or low-molecular-weight heparin within 24 hours.
- Biomarker or test result
- Brain perfusion scan (CT or MR) must show a target mismatch profile if treatment starts 4.5 to 24 hours after last known well.
Main reasons for not taking part
- Bleeding in the brain on a scan, or any past bleeding in the brain
- Planned endovascular treatment or planned DOAC reversal treatment
- Allergy to tenecteplase
- Pregnant or breastfeeding
- Serious bleeding within the past 3 weeks, or major surgery or severe trauma within 3 months
Read by machine on 12 November 2026.
Where in China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Yanting ChenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.