Acute ischemic stroke
Conditions
Interventions
Sonidegib plus Endovascular Treatment Group:Sonidegib plus Endovascular Treatment
Placebo plus Endovascular Treatment Group:Placebo plus Endovascular Treatment
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Time from onset to randomization within 6 hours; 3. Anterior circulation ischemic stroke was preliminarily determined according to clinical symptoms or imaging examination; 4. Baseline National Institutes of Health Stroke Scale [NIHSS] score 8-25; 5. The neuroimaging examination upon admission should also meet the following imaging standards: a) MRI criterion: ASPETS 0 to 5 or volume of DWI (Diffusion-weighted Imaging) restriction >=5 mL and =5 mL and <=70 mL. 6. Computed tomography angiography (CTA)/magnetic resonance angiography (MRA)/digital subtraction angiography (DSA) confirmed occlusion of intracranial segment of internal carotid artery and middle cerebral artery M1 and M2 segment, who decided to receive endovascular treatment; 7. Written informed consent signed by patients or their family members.
Exclusion criteria
Exclusion criteria: 1. CT or MR evidence of intracranial hemorrhage; 2. mRS score >= 2 before onset; 3. Pregnant or lactating women; 4. Allergy to contrast agents; 5. Allergy to Sonidegib or had contraindications of Sonidegib; 6. Currently participating in other clinical studies; 7. Systolic blood pressure > 185mmHg or diastolic blood pressure > 110mmHg, and oral antihypertensive drugs cannot control it; 8. Genetic or acquired bleeding tendency, deficiency of anticoagulant factors; or taking oral anticoagulants with INR>1.7; 9. Blood glucose 22.2mmol/L (400mg/dl); 10. Arterial tortuosity that would prevent the device from reaching the target vessel; 11. History of bleeding within the past month (gastrointestinal and urinary tract bleeding); 12. Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220µmol/L(2.5mg/dl)); 13. Recent history of strong and moderate CYP3A inducers, including but not limited to carbamazepine, efavirenz, modafinil, phenobarbital, phenytoin sodium, rifampicin, rifapentine etc., to avoid drug interactions with sonidegib; 14. Any terminal illness with life expectancy less than 6 months; 15. Unable to complete follow-up 16. Intracranial aneurysm, arteriovenous malformation; 17. Brain tumors with imaging evidence of mass effect; 18. Macular edema; 19. Mobitz type II second-degree/third-degree atrioventricular block or sick sinus syndrome or medical history. 20. Planning for parenthood in the next six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at 90 days;Imaging 72 hour Infarct Volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Events;Change of Infarct Volume;Modifed Rankin Scale Score at 90 days;Modified Rankin Scale Score of 0 to 1 at 90 days;Modified Rankin Scale Score of 0 to 2 at 90 days;NIHSS score change at 24hours after EVT;NIHSS score change at 5-7 days; | — |
Countries
China
Contacts
Public ContactQingwu Yang
The Second Affiliated Hospital of Army Medical University
Outcome results
None listed