NCT00200356已完成4 期
Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke
Shionogi0 个研究点目标入组 401 人开始时间: 2004年8月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 主要终点
- the Rate of Patients With a Modified Rankin Scale Score of 0-1
研究概览
简要总结
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients can be receive drug treatment within 24 hours after stroke onset
- •Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale
- •Patients with motor dysfunction of upper and/or lower extremities
- •Patients aged 20 years or older when giving informed consent
排除标准
- •Serum creatinine of >1.5 mg/dL
- •Embolic infarction
- •Intracranial haemorrhage
- •Large infarction with severe consciousness
- •Transient ischemic attack (TIA)
- •A modified Rankin Scale score of ≥2 before stroke onset
- •Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset
- •Patients were receive surgical treatment or intravascular treatment
- •With severe complications (cirrhosis, heart failure, etc.)
- •Treating malignant tumor
- •Pregnant or possibly pregnant women, nursing mothers
- •History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity
- •Less than 3 months since any other clinical trial or postmarketing study
研究组 & 干预措施
Edaravone
Experimental
干预措施: Edaravone (Drug)
Ozagrel
Active Comparator
干预措施: Sodium Ozagrel (Drug)
结局指标
主要结局
the Rate of Patients With a Modified Rankin Scale Score of 0-1
时间窗: 3 months
The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
次要结局
- Barthel Index Score(3 months)
- Baseline NIH Stroke Scale Score(Before treatment initiation)
- NIH Stroke Scale Score at 14 Days(14 days)
- NIH Stroke Scale Score at 1 Month(1 month)
- NIH Stroke Scale Score at 3 Months(3 months)
- Japan Stroke Scale (Motor Function) Score at 14 Days(14 days)
- Japan Stroke Scale (Motor Function) Score at 1 Month(1 month)
- Japan Stroke Scale (Motor Function) Score at 3 Months(3 months)
- Modified Rankin Scale Score(6 months)
研究者
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