Stroke treatment showdown: is removing the clot alone enough?
NCT ID NCT05827042
First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This study compares two treatments for a severe type of stroke caused by a blockage in a major artery at the base of the brain. Some patients will get a clot-busting drug through a vein followed by a procedure to remove the clot, while others will have the clot removal procedure alone. The goal is to see if skipping the drug leads to similar or better recovery and safety. About 338 adults who can be treated within 4.5 hours of stroke onset will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Alteplase or Tenecteplase (clot-busting drugs given through a vein)
- What this could lead to
- If successful, this could show that removing the clot directly is just as good or better than giving a clot-busting drug first, potentially simplifying treatment for this severe stroke type.
- What could go wrong
- This is a Phase 3 trial but still relatively small (338 people). The results may not apply to all stroke patients, and there is a risk that skipping the clot-busting drug could lead to worse outcomes or more disability.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
338 people
The number who actually took part.
- Started
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May 2023
- Finished
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Apr 2026
- Lead sponsor
-
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
-
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. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery; 2. Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion; 3. Patient's age ≥ 18 years; 4. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery; 5. Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria; 6. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10; 7. The patient or patient's legal representative signs the informed consent form. Exclusion Criteria: 1. CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed); 2. Pre-stroke modified Rankin scale (mRS) score ≥ 2; 3. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) \<5; 4. Pregnant or lactating women; 5. Allergy to contrast agent or nitinol alloy; 6. Life expectancy\<1 year; 7. CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment; 8. Participating in other clinical trials; 9. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which can not be controlled by antihypertensive drugs; 10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; oral anticoagulant with international normalized ratio (INR) \> 1.7; or novel oral anticoagulant within prior 48 hours; 11. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L), platelet\< 100\*109/L; 12. Renal insufficiency defined as serum creatinine \>2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate \<30 mL/min, need for hemodialysis or peritoneal dialysis; 13. Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc); 14. The patient has acute ischemic cerebral infarction within 3 months from randomization; 15. The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis; 16. The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition; 17. CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle; 18. Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination; 19. CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion; 20. Patients with intracranial tumors (except small meningiomas); 21. Patients who received intravenous thrombolytics treatment before the randomization.
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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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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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