The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in INR value
研究概览
简要总结
This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.
详细描述
There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :
- Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal
- Treatment II : 1 tablet of aspirin 80 mg once daily, after meal
- Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal
Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.
Physiotherapy will be provided to the subjects by the assigned Physiotherapist.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 20-80 years old
- •Having non-bleeding stroke in CT scan examination
- •Having stroke attack onset ≤ 96 hours
- •Living in 100 km from RSUP Dr Sardjito Jogjakarta
排除标准
- •Having recurrence stroke
- •Having Transient Ischemic Attack (TIA)
- •Have been regularly taking anti-aggregation agent
- •Having intracerebral and subarachnoid bleeding stroke
- •Subjects and their family do not know when the stroke symptoms appeared
- •History of haemostasis disorder
- •History of or will have surgery within 6 months prior to screening
研究组 & 干预措施
Treatment I
1 tablet of DLBS1033 490 mg thrice daily, after meal
干预措施: DLBS1033 (Drug)
Treatment II
1 tablet of aspirin 80 mg once daily, after meal
干预措施: Aspirin (Drug)
Treatment III
1 tablet of clopidogrel 75 mg once daily, after meal
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Change in INR value
时间窗: 3 Months
Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)
次要结局
- Change in PT(3 Months)
- Change in aPTT(3 Months)
- Change in Gadjah Mada Stroke Scale(3 Months)
- Change in Barthel Index(3 Months)