New combo treatment could improve outcomes in major stroke
NCT ID NCT05701956
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving a clot-busting drug (tenecteplase) before mechanical clot removal helps people with a severe type of stroke caused by a blockage in the basilar artery. The trial included 330 adults who were treated between 4.5 and 24 hours after stroke symptoms began. The main goal was to see if the combination led to better recovery (less disability) at 90 days compared to clot removal alone.
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 offer a better treatment for severe strokes by combining a clot-busting drug with mechanical clot removal.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. Adding tenecteplase may increase bleeding risk without improving outcomes.
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
-
330 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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May 2025
- 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
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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. 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 4.5-24 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 cases of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery; 5. Patients presenting with acute ischemic stroke eligible using standard criteria (except for time window) to receive both endovascular thrombectomy and intravenous thrombolysis; 6. Baseline National Institutes of Health Stroke Scale (NIHSS) score≥ 10 at the time of neuroimaging; 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 of ≥ 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, vascular 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 cannot be controlled by antihypertensive drugs; 10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; or 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) or a glomerular filtration rate \<30 mL/min or the 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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- Can a Clot-Removal procedure turn the tide in severe stroke?
- Can a faster, Higher-Power heart ablation beat the standard for AFib?
- Clot-Removal procedure may offer hope for severe brain stem strokes
- Stroke treatment showdown: is removing the clot alone enough?
- New drug could extend window for treating deadly stroke