Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients Wit… (NCT05885919) | Clinical Trial Compass
UnknownPhase 3
Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke
China212 participantsStarted 2023-07-01
Plain-language summary
The primary objective of this study was to evaluate the efficacy and safety of initiation of edaravone dextivel therapy compared with placebo in patients with acute ischaemic stroke (early and late) and to explore the optimal time window for "brain cell protective therapy" of edaravone dexborneol.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-80 years old, gender is not limited;
* Clinically confirmed acute ischemic stroke;
* Within 6 hours of the onset of this stroke;
* NIHSS score of 4-24 at enrollment;
* mRS score before onset≤ 1 point;
* Subject and subject's agent are able and willing to sign informed consent.
Exclusion Criteria:
* CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
* Previously known severe liver or kidney insufficiency (ALT or AST is greater than 3.0×ULN; serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or dialysis;
* Systolic blood pressure≥220 mmHg or \<90mmHg;
* Recent stroke within prior 1 monthï¼›
* 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 deficiency disease, or thrombocytopenic disease, etc.;
* Pregnancy, lactation, or planned pregnancy within 90 days;
* Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia;
* Those with a malignant tumor, severe systemic diseases, or predict survival time \<90 days;
* Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study;
* The investigators consider the patients…
What they're measuring
1
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
Timeframe: 90 days
Trial details
NCT IDNCT05885919
SponsorXiangya Hospital of Central South University