Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

Официальное название

Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Обзор

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Подробное описание

In this study, 1200 patients with acute ischemic stroke within 48 hours from the onset are included in several centres in China according to the principles of randomization, double-blind, and parallel control. The experimental group receives basic treatment and edaravone dexborneol injection for 7 consecutive days, and sequentially receives a sublingual dose of edaravone dexborneol for 21 consecutive days. The placebo group receives basic treatment and edaravone dexborneol placebo injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol placebo drug for 21 consecutive days. Two groups will be followed up at day 90 to evaluate the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Вмешательства

• Препарат Edaravone dexborneol
  Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.
• Препарат Placebo
  Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Первичные конечные точки

• modified rankin scale (mRS) score ≤ 1 [Срок оценки: Day 90 after randomization]

Вторичные конечные точки (5)

• Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels [Срок оценки: Day 3 after randomization]
• Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels [Срок оценки: Day 7 after randomization]
• NIHSS score on day 7 [Срок оценки: Day 7 after randomization]
• mRS score ≤ 2 [Срок оценки: Day 90 after randomization]
• Distribution of mRS score [Срок оценки: Day 90 after randomization]

Критерии участия

Критерии включения

• Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
• Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset.
• Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
• modified Rankin Scale (mRS) score of 1 or less before onset.
• Did not receive edaravone dexborneol treatment before enrollment;
• The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.

Критерии исключения

• Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.
• Transient ischemic attack (TIA);
• Posterior circulation stroke;
• Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
• Severe disturbance of consciousness: the item score of 1a consciousness level of NIHSS was more than 1;
• Patients with severe mental disorders and dementia;
• Systolic blood pressure after blood pressure control is still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg;
• Severe cardiac insufficiency, dissection and acute pericarditis; Severe liver insufficiency, ALT or AST > 3.0 × ULN; Or severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc;Severe renal insufficiency, Serum Creatinine (SCr) is greater than 200μmol/L, Creatinine Clearance (CrCl) is less than 30 ml/min or receiving hemodialysis; Or suffering from severe systemic diseases, the estimated survival time is less than 90 days;
• Complicated with malignant tumor or undergoing anti-tumor treatment;
• Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide.
• Patients during pregnancy, lactation and planned pregnancy;
• Allergic to dexborneol or edaravone or excipients;
• Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;
• Patients who are unwilling to be followed up，and the investigators consider the patients are not suitable for this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT06645522 · ED-AIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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