Last updated: August 20, 2023
Sponsor: Beijing Tiantan Hospital
Overall Status: Completed
Phase
3
Condition
Stroke
Cerebral Ischemia
Thrombosis
Treatment
Edaravone Dexborneol placebo
Edaravone Dexborneol Concentrated Solution for injection
Clinical Study ID
NCT05249920
NCRC-2021-01
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 - 80 years, male or female;
- Clinically diagnosed as acute anterior ischemic stroke, artery occlusion occurred atthe terminal of the intracranial carotid artery, T-shaped bifurcation or M1 segment ofthe middle cerebral artery;
- Within 24 hours of stroke onset;
- Eligible for other imaging indications for bridging therapy or direct mechanicalthrombectomy: ASPECTS ≥6 certified by the latest brain CT imaging; Patients within 6-16 hours afterstroke onset should meet the mismatch criteria, which was defined as infarction corevolume <70 ml, mismatch ratio ≥1.8 and the ischemic volume > 15 ml (DEFUSE-3Criteria); or NIHSS score ≥ 10 with infarction -core volume < 31 cm3, or NIHSS score ≥ 20 with infarction core volume ≤ 51 cm3 (DAWN Criteria); Patients within 16-24 hoursafter stroke onset should meet the mismatch criteria, which was defined as NIHSS score ≥ 10 with infarction-core volume < 31 cm3, or NIHSS score ≥ 20 with infarction-corevolume ≤ 51 cm3 (DAWN Criteria);
- Planned to receive bridging therapy (endovascular therapy after intravenous alteplase)or direct endovascular therapy;
- Pre-morbid modified Rankin Scale ≤1;
- 6 ≤ NIHSS ≤ 25 before endovascular therapy;
- Signed informed consent from subjects or legally authorized representatives
Exclusion
Exclusion Criteria:
- CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subduralhematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
- Had been given any intravenous thrombolytic drug other than alteplase before bridgingtherapy;
- Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials;
- Prior receipt of edaravone or any other neuroprotective drugs;
- History of congenital or acquired hemorrhagic disease, coagulation factor deficiencydisease, or thrombocytopenic disease, etc.;
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg afterantihypertensive treatment;
- Serum alanine aminotransferase (ALT) or aspartate transaminase (AST) elevates over 3times of upper limit of normal;
- Recent or current serum creatinine is known to exceed 1.5 times the upper limit ofnormal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;
- Pregnancy, lactation, or planned pregnancy within 90 days;
- Those who cannot complete informed consent or follow-up treatment due to severe mentaldisorder or dementia;
- Those with a malignant tumor, severe systemic diseases, or predict survival time <90days;
- Participate in another interventional clinical study within 30 days beforerandomization or participate in another interventional clinical study.
Study Design
Total Participants: 1362
Treatment Group(s): 2
Primary Treatment: Edaravone Dexborneol placebo
Phase: 3
Study Start date:
March 18, 2022
Estimated Completion Date:
May 19, 2023
Study Description
Connect with a study center
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing 100070
ChinaSite Not Available

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