NCT05035953Unknown2 期
Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 主要终点
- The proportion of symptomatic intracranial hemorrhage
研究概览
简要总结
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.
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
- Double (Participant, Investigator)
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
- •Acute ischemic stroke;
- •18 to 80 years of age;
- •There are clear signs of neurological deficit: 8≤NIHSS score≤24;
- •Received alteplase thrombolysis therapy within 4.5 hours after onset;
- •Patients signed written inform consent
排除标准
- •Patients need endovascular therapy or bridge therapy;
- •Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- •Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months;
- •Intracranial or intraspinal surgery within 3 months;
- •Active visceral hemorrhage
- •Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site;
- •Unknown onset time;
- •Rapid improvement of symptoms or mild symptoms before thrombolysis therapy;
- •A platelet count below 100,000/mm3 indicates a propensity for acute bleeding;
- •Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- •Patients with severe mental disorders and dementia;
- •ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
- •Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
- •Patients with malignant tumors or severe systemic disease;
- •allergic to edaravone , (+)-Borneol or related excipients;
- •Pregnant or lactating women;
- •Have major surgery within 4 weeks before enrollment;
- •Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
- •The investigators consider the patients are not suitable for this trial.
研究组 & 干预措施
Edaravone
Experimental
Edaravone Dexborneol injection
干预措施: Edaravone Dexborneol (Drug)
Placebo
Placebo Comparator
Edaravone Dexborneol matching injection
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of symptomatic intracranial hemorrhage
时间窗: 36-48 hours
次要结局
- The proportion of symptomatic intracranial hemorrhage(7 days)
- The proportion of intracranial hemorrhage(36-48 hours, 7 days)
- Vascular recanalization(36-48 hours)
- Blood Brain Barrier Permeability(36-48 hours)
- Proportion of Encephaledema(36-48 hours)
- Proportion of Death(90 days)
- The change in the NIH stroke scale (NIHSS) from the baseline(36-48 hours, 7, 14 and 90 days)
- The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1(90 days)
- The proportion of Participants With Barthel Index (BI) score greater than or equal to 95(14 and 90 days)
研究者
Qiang Dong
MD, PhD, Director of Neurology Department
Huashan Hospital
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