Can a Clot-Buster help stroke patients on blood thinners?
NCT ID NCT07092709
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a drug called tenecteplase in people who have had a stroke and recently took a blood thinner (DOAC). The goal is to see if the drug helps them recover better after 90 days. About 912 participants will receive either tenecteplase or a placebo within 24 hours of their stroke.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tenecteplase (a clot-busting drug)
- What this could lead to
- If it works, this could provide a safe way to treat stroke in patients who have recently taken blood thinners, potentially improving their recovery.
- What could go wrong
- This is a Phase 3 trial, but it's still uncertain whether tenecteplase will be safe or effective in this specific group. There is a risk of bleeding, especially since patients are on blood thinners.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 912 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years or older. 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: 1. Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
RECRUITINGGuangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Cancer patients face a hidden Second-Stroke threat, and 24 hospitals are mapping it
- Can tiny neural exosomes help the brain heal after a severe stroke?