Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- modified rankin scale (mRS) score ≤ 1
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Edaravone dexborneol group
Edaravone dexborneol injection 37.5mg every 12 hours for 7 days and a sublingual dose of edaravone dexborneol 36 mg twice a day for 21 days.
干预措施: Edaravone dexborneol (Drug)
Placebo group
Placebo injection every 12 hours for 7 days and a sublingual dose of placebo drug twice a day for 21 days.
干预措施: Placebo (Drug)
结局指标
主要结局
modified rankin scale (mRS) score ≤ 1
时间窗: Day 90 after randomization
The proportion of patients with mRS score of 1 or less on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.
次要结局
- Distribution of mRS score(Day 90 after randomization)
- Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels(Day 7 after randomization)
- NIHSS score on day 7(Day 7 after randomization)
- mRS score ≤ 2(Day 90 after randomization)
研究者
Yi Yang
Vice President of the First Hospital of Jilin University
The First Hospital of Jilin University