Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion

Launched by THE FIRST AFFILIATED HOSPITAL OF UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients who have experienced a stroke due to a blockage in the basilar artery, which is a major artery in the back of the brain. Researchers want to find out if giving a medication called tenecteplase through an intravenous (IV) line, along with a procedure called endovascular thrombectomy (EVT), is more effective than EVT alone when given between 4.5 to 24 hours after the stroke starts. This study is currently recruiting participants aged 18 and older who meet certain criteria, including having specific types of artery blockages confirmed by imaging tests and a stroke severity score indicating moderate to severe symptoms.

If eligible and you choose to participate, you can expect to receive either the combination treatment or just the EVT, and you will be monitored closely for 90 days afterward to assess your recovery. It’s important to note that there are several criteria that could prevent someone from joining the study, such as having certain medical conditions or previous strokes. If you are interested or have questions, it’s a good idea to discuss this with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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;