NCT00823875已完成4 期
A Randomized, Control, Open Label, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
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
- 200
- 试验地点
- 1
- 主要终点
- After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
研究概览
简要总结
Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
详细描述
Efficacy index:
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Pharmacokinetics:
After 12 weeks of treatment, the study medication plasma concentration including of Probucol ,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured.
Safety evaluation:
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40～80-year-old male or female
- •By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
- •With atherosclerosis, atherosclerosis should meet at least one of the conditions as below:
- •Clarified diagnosis of type 2 diabetes before
- •Clarified diagnosis of primary hypertension before
- •Clarified diagnosis of Atherosclerotic stenosis in any 2 or more than 2 regions as cerebral artery, carotid, extremity artery and coronary by conformation of ultrasonic or angiography result
- •Has Aspirin regularly for more than 1 month before registration
- •Informed Consent Form signature
- •Exclusion criteria：
- •Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin
- •Had lipid-lowing agents within the last 3 months ( except Statins)
- •Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
- •Had acute cerebral infarction within the last 1 month
- •Has cardiogenic cerebral embolism
- •At the registration ,Modified Rankin Scale ≥ 4
- •Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage, gastrointestinal tract hemorrhage, etc.)
- •Had a myocardial infarction, angina pectoris within the last 3 months
- •Congestive heart failure
- •Is pregnant, is potentially pregnant, or is breastfeeding
- •Severe hepatic inadequacy or severe renal inadequacy (AST or ALT is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range)
- •Persistent or hardly controlled hypertension (such as malignant hypertension, BP> 160/100 mmHg)
- •Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
- •Has a medical history that includes a cardiac syncope or a primary syncope
- •Has a condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
- •Has severe diseases (such as, malignant tumor, severe anaemia, severe hematologic diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, etc.)
- •Registered other clinical trails within the last 3 months
- •Has vasculitis, moyamoya disease and other non-atherosclerosis vascular diseases
- •Other conditions that could exclude the subject from this study by doctor's judgment
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Cilostazol group (Drug)
2
Experimental
干预措施: Probucol group (Drug)
3
Experimental
干预措施: Cilostazol + Probucol group (Drug)
4
Other
Control Group
干预措施: control group (Drug)
结局指标
主要结局
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
时间窗: 12 week
次要结局
未报告次要终点
研究者
研究点 (1)
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