Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users
NCT ID: NCT07092709
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
912 participants
INTERVENTIONAL
2025-08-14
2028-12-31
Brief Summary
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Detailed Description
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Study intervention: (1) Participants in the intervention group will receive tenecteplase 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. (2) Participants in the control group will receive matched intravenous placebo in the same approach. All participants will receive standard medical treatment.
A total of 912 participants are anticipated to be recruited for this study, with 456 participants in each group (1:1 ratio).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intravenous tenecteplase
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.
Matched placebo
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinically diagnosed with acute ischemic stroke.
3. 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.
4. Study intervention (IVT or placebo) can be started
1. within 4.5 hours of last known well (LKW). OR
2. 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.
5. 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.
6. Written informed consent signed by patients or their legally authorized representatives.
Exclusion Criteria
2. Allergic to tenecteplase.
3. Pre-stroke mRS≥2
4. Planned endovascular treatment.
5. Currently on dual antiplatelet therapy in addition to DOAC therapy.
6. Planned DOAC reversal treatment (including Idarucizumab, Andexanet and tranexamic acid).
7. Hypodensity on non-contrast CT estimates to be ≥ 1/3 MCA territory.
8. Severe head trauma or other severe trauma in the last 3 months.
9. Intracranial tumor, arteriovenous malformation and large-size aneurysm (≥10 mm) found before enrollment.
10. Intracranial surgery, intraspinal surgery or other major surgeries within 3 months before enrollment (based on the assessment of the investigators)
11. Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
12. Active visceral bleeding.
13. Aortic arch dissection confirmed by examination or medical history.
14. Infective endocarditis confirmed by examination or medical history.
15. Platelet count less than 100 × 10\^9 /L.
16. Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
17. Pregnant or lactating women.
18. Blood glucose \<50 mg/dl (2.78mmol/L) or \>400 mg/dl (22.2mmol/L) during screening.
19. Uncontrolled hypertension with persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to medical management.
20. Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.
21. Participating in other trials.
22. 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.
18 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Yamei Tang
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Raul G. Nogueira
Role: PRINCIPAL_INVESTIGATOR
UPMC Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh
Locations
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYSKY-2025-484-01
Identifier Type: -
Identifier Source: org_study_id