Can a Low-Dose clot buster boost recovery after stroke clot removal?
NCT ID NCT07727395
First seen Jul 27, 2026 · Last updated Aug 21, 2026 · Updated 6 times
Summary
This trial investigates whether giving a low dose of the clot-busting drug alteplase directly into the brain artery, right after successful mechanical clot removal, can improve recovery in people with a severe stroke caused by a large vessel blockage. About 416 adults who have had a stroke and achieved good blood flow restoration within 24 hours will be randomly assigned to receive either the extra drug plus standard care or standard care alone. The main goal is to see if more people regain functional independence—being able to carry out daily activities without help—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
- a clot-busting drug called alteplase, given directly into the brain artery after mechanical clot removal
- What this could lead to
- If it works, this approach could become a new standard treatment to improve functional independence after a severe stroke.
- What could go wrong
- This is a Phase 3 trial, but the added drug may increase the risk of bleeding in the brain. The benefit may not outweigh the risk 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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About 416 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 old. 2. No significant pre-stroke functional disability (pre-stroke mRS 0-1) 3. Clinical diagnosis of acute ischemic stroke with anterior LVO 4. Time from symptom onset to randomization within 24 hours, including wake-up stroke or unwitness stroke; the onset time refers to "Last Known Well" (LKW). 5. Baseline NIHSS of 6 - 25 6. Non-contrast CT (NCCT) or diffusion-weighted imaging (DWI)-MRI Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. For patients with available perfusion imaging (CTP/MRP), additional criteria include: Ischemic core volume ≤ 70mL; Mismatch volume ≥ 15 ml; Mismatch ratio ≥ 1.8 7. Evidence of oclussion of the intracranial segment of the internal carotid artery (ICA), or M1 or M2 segment of the middle cerebral artery (MCA) on CT angiography (CTA) or MR angiography (MRA) 8. Treated with EVT resulting eTICI score of 2b-3. Patients with an eTICI score of 2b-3 on the diagnostic cerebral angiography before MT are also eligible for the study. 9. Informed consent obtained from patient or acceptable patient surrogate. Exclusion Criteria: 1. mRS score ≥ 2 before stroke onset 2. Anticipated advanced comorbid disease with life expectancy \< 12 months 3. Acute head trauma 4. Severe hypertension with SBP \> 185 mmHg or DBP \> 110 mmHg and refractory to treatment. 5. Any active or recent major bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 30 days. 6. Contraindication to recombinant human tissue plasminogen activator (rt-PA) (except time to therapy). 7. Women who are pregnant at stroke onset. 8. Recent intracranial surgery in the past 30 days. 9. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency. 10. Coagulation disorder with INR \> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset). 11. Platelet count \< 50 G/L. 12. Blood glucose \< 2,8 mmol/L (50 mg/dl) or \> 22,2 mmol/L (400 mg/dl) 13. Known severe renal insufficiency with glomerular filtration rate \< 30 ml/min or blood creatinine \> 220 µmol/L (2,5 mg/dl). 14. Requiring hemodialysis or peritoneal dialysis 15. Suspected vascular occlusion as a result of infective endocarditis 16. Suspected cerebral vasculitis based on medical history and/or angiographic evaluation. 17. Suspected aortic dissection 18. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast, heparin. 19. Acute ischemic stroke with significant mass effect or evidence of midline shift on baseline neuroimaging, or clinical signs of brain herniation 20. Suspected acute ischemic stroke involving multiple vascular territories or occlusion of two or more distinct vascular systems on neuroimaging 21. Evidence of intracranial hemorrhage (including hemorrhagic transformation) on neuroimaging 22. Brain tumor (with significant mass effect) 23. Stent placement and other situations during the EVT procedure that requires antiplatelet therapy or anti coagulation within the first 24 hours. 24. Extracranial segment occlusion of the ICA and post-procedural etiology suggests vascular dissection. 25. Intravenous heparin administration (however, heparinised saline flushes are allowed) 26. Procedure time \> 90 min 27. Number of thrombectomy passes \> 5 28. Complications occur during EVT: Vascular rupture, dissection, or contrast extravasation 29. Complete clinical recovery after rapid recanalization. 30. Participation in other interventional randomized clinical trials that may confound the outcome assessment of the study. 31. 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). 32. Unlikely to be available for 90-day follow-up
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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
10 sites. 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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175 Military Hospital
NOT_YET_RECRUITINGHo Chi Minh City, 700000, Vietnam
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Can Tho Central General Hospital
RECRUITINGCan Tho, 900000, Vietnam
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Chau Doc General Hospital
RECRUITINGAn Giang, 90000, Vietnam
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Da Nang Hospital
RECRUITINGDa Nang, 550000, Vietnam
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Hanoi Medical University Hospital
NOT_YET_RECRUITINGHà Nội, 100000, Vietnam
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Hue Central Hospital
RECRUITINGHuế, 530000, Vietnam
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Military Hospital 103
NOT_YET_RECRUITINGHà Nội, 100000, Vietnam
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People's Hospital 115
RECRUITINGHo Chi Minh City, 700000, Vietnam
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Thong Nhat Hospital
RECRUITINGHo Chi Minh City, 700000, Vietnam
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Viet Tiep Friendship Hospital
RECRUITINGHaiphong, 180000, Vietnam
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Natural capsule tested as Add-On for stroke recovery
- Could a second Clot-Buster boost stroke recovery?
- Can a blood Clot's inflammation predict stroke recovery?
- Could adding Clot-Busting drugs before surgery boost stroke recovery?
- Stroke treatment upgrade: adding a Clot-Buster after clot removal may boost recovery