acute ischemic stroke
Conditions
Interventions
Butylphthalide:Butylphthalide injection
Edaravone dexborneol:Edaravone dexborneol injection
Butylphthalide Combined with Edaravone dexborneol:Butylphthalide injection Combined with Edaravone dexborneol injection
Sponsors
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with acute ischemic stroke according to World Health Organization (WHO) criteria; 2. Ability to receive thrombectomy within 24 hours of stroke onset:; 3. Age >=18 years, regardless of gender; 4. Baseline NIHSS score ranging 6 from 20; 5. Patients who underwent mechanical thrombectomy with successful recanalization (eTICI grade 2B-3); 6. Signed informed consent;
Exclusion criteria
Exclusion criteria: 1. mRS score >1 at randomisation (premorbid historical assessment); 2. Diagnosed with intracranial haemorrhagic diseases or post-thrombectomy intracranial hemorrhage (including cerebral hemorrhage, subarachnoid hemorrhage, intra/extracranial hematoma, etc; ECASS grade PH2); 3. Already use neuroprotective agents or any drugs containing neuroprotective ingredients between onset and randomization; 4. Uncontrolled hypertension (systolic blood pressure >=200 mmHg or diastolic blood pressure >=120 mmHg after treatment); 5. With history of coagulation disorders, haemorrhagic diathesis, neutropaenia or thrombocytopaenia; 6. With history of chronic hepatopathy, liver or kidney dysfunction (>=3×upper limit of normal alanine transaminase or >=2× upper limit of normal creatinine); 7. With history of severe cardiopulmonary diseases judged by Investigators; 8. With history of bradycardia (heart rate <60 beats per minute) or sick sinus syndrome; 9. Having severe non-cardiovascular comorbidity with life expectancy <3 months or failed to follow the study for other reasons; 10. History of drug or food allergy, or known to be allergic to the composition of drugs in this study; 11. Contraindications to digital subtraction angiography procedure, including severe allergy for contrast agent with or without iodine; 12. Pregnancy or lactation, or childbearing women, with documented negative pregnancy test, but without reliable contraception; 13. Incapable to follow this study for mental illness and cognitive or emotional disorders; 14.Participation in other clinical trials within 3 months or concurrent conflicting therapies; 15. Unsuitable for this study in the opinion of the investigators;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score;hepatorenal function; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS score;Hemorrhagic events;Incidence of severe adverse events;Barthel Index score;All-cause mortality;Incidence of recurrent ischemic stroke or vascular event;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactYun Xu
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed