NCT03248401已完成4 期
Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of carotid artery atherosclerosis
研究概览
简要总结
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 80 years
- •Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
- •Carotid plaque on 3D ultrasound
排除标准
- •Acute bleeding or bleeding tendency
- •Diagnosed with heart failure
- •Suggestive of ischemia on ECG
- •Uncontrolled hypertension
- •Recently diagnosed with peptic ulcer disease
- •Taking other antiplatelet agents
- •Hypersensitivity to salicylic acid
- •Aspirin induced asthma
- •Severe kidney, liver, heart disease
研究组 & 干预措施
Cilostazol group
Experimental
Cilostazol 200 mg or maximal tolerate dose
干预措施: Cilostazol (Drug)
Aspirin group
Active Comparator
Aspirin 100 mg
干预措施: Aspirin (Drug)
结局指标
主要结局
Change of carotid artery atherosclerosis
时间窗: 6 months
Plaque composition
次要结局
- Change of carotid artery atherosclerosis 2(6 months)
- Change of carotid artery atherosclerosis 3(6 months)
- Change of carotid artery atherosclerosis 1(6 months)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital
研究点 (1)
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