Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• 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.

• 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.