Could a second Clot-Buster boost stroke recovery?
NCT ID NCT05856851
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether giving the clot-busting drug alteplase directly into the brain artery, right after a mechanical thrombectomy has reopened a blocked vessel, can improve recovery from acute ischemic stroke. The study enrolls adults with large-vessel blockages in the front part of the brain, within 24 hours of symptom onset. Participants are randomly assigned to receive either standard care or standard care plus intra-arterial alteplase. The main goal is to see if more people achieve a good functional outcome (able to live independently) at 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alteplase (a clot-busting drug) given directly into the artery after mechanical thrombectomy
- What this could lead to
- If effective, this could improve functional recovery and reduce disability for people who have had a major ischemic stroke, potentially changing standard post-thrombectomy care.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. Adding a clot-buster after successful reopening of the vessel may increase bleeding risk in the brain, and benefits may not outweigh risks for all patients.
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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324 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Nov 2025
- 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. Aged 18 years or older. 2. Clinical diagnosis of acute ischemic stroke. 3. Time from symptom onset to randomization within 24 hours, including wake-up stroke or no-witness stroke; the onset time refers to "Last Known Well" (LKW). 4. CTA or MRA confirmed occlusion of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis. Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography before mechanical thrombectomy are also eligible for the study. 5. Baseline NIHSS of 6-25. 6. NCCT/DWI-MRI ASPECTS ≥ 6; 7. Pre-stroke mRS score ≤ 1, or mRS \>1 but not related to neurological disease (e.g., amputation, blindness). 8. Signed informed consent. Exclusion Criteria: 1. Contraindication to rt-PA (except time to therapy). 2. Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy. 3. Angiographic evaluation showing dissection, severe stenosis, or complete occlusion of the carotid artery, which requires the use of carotid artery stents during the endovascular procedure. 4. Suspected cerebral vasculitis based on medical history and/or angiographic evaluation. 5. Women who are pregnant or breastfeeding. 6. Participation in other clinical trials. 7. Preoperative intracranial hemorrhage confirmed by cranial CT or MRI. 8. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency. 9. Coagulation disorder with INR \> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset). 10. Platelet count \<50X10\^9/L. 11. Suspected vascular occlusion as a result of infective endocarditis. 12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl). 13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast. 14. Suspected aortic dissection. 15. Previous parenchymal organ surgery or biopsy in the last 1 month; 16. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month; 17. SBP \> 185 mmHg or DBP \> 110 mmHg refractory to treatment. 18. Anticipated life expectancy \< 6 months (e.g., malignancy, severe cardiopulmonary disease, etc.). 19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
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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.
Contacts and locations
Locations
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Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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