NCT00886574Unknown4 期
Multi-Center, Randomized, Open Label Study of the Efficacy of Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events With Korean Type 2 DM Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group
研究概览
简要总结
This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus with high risk of macrovascular complications; high risk is one or more as follows:
- •Hypertension (≧ 140/90 or anti-hypertensive therapy)
- •Hypercholesterolemia (LDL-C > 130 mg/dL or anti-hyperlipidemic therapy)
- •TG > 200 mg/dL
- •Non proliferative retinopathy or macular edema
- •Microalbuminuria or macroalbuminuria
- •Patients on no anti PLT drug history
- •Patients who are agree with this research
排除标准
- •Type 1 diabetes mellitus
- •Macrovascular complication history
- •Uncontrolled hypertension, unstable angina history
- •Congestive heart failure
- •Bleeding tendency
- •Chronic liver disease (ALT > 100 or AST > 100) or Chronic renal disease creatinine > 3.0 mg/dl)
- •Anemia (hemoglobin < 10 mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- •Pregnant or lactation women
- •Plan to be revascularized in 4 weeks
- •Plan to go to surgery or invasive intervention in 4 weeks
- •Plan to need to admission for acute cardiovascular disease in 4 weeks
- •Contraindication of this medication
- •Other anti-PLT drug therapy
研究组 & 干预措施
Aspirin
Active Comparator
Aspirin 100 mg once a day
干预措施: Aspirin (Drug)
Cilostazol
Active Comparator
Cilostazol 200 mg (50 mg 2T twice per day)
干预措施: Cilostazol (Drug)
结局指标
主要结局
Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group
时间窗: every 6 months following randomization, for 48 months
次要结局
- Events of the ischemic heart disease(every 12 months following randomization, for 48 months)
- Events of cerebrovascular disease(every 12 months following randomization, for 48 months)
- Events of peripheral vascular disease(every 12 months following randomization, for 48 months)
- Events of hemorrhagic vascular complication(every 12 months following randomization, for 48 months)
研究者
研究点 (5)
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