Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The changes in reactive hyperemia index (RHI)
研究概览
简要总结
Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.
详细描述
The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CHA2DS2-VASc score above 2
排除标准
- •severe peripheral arterial disease (greater than a Fontaine IIb category)
- •grade 4 or higher cerebral infarction on the Modified Rankin Scale
- •proven coronary artery disease by coronary angiogram
- •severe hepatic or renal dysfunction
- •uncontrolled congestive heart failure
- •uncontrolled hypertension or diabetes mellitus
- •hematologic disorders
- •allergy or hypersensitivity to the investigational drugs
- •pregnant or lactating women or women wishing to become pregnant
研究组 & 干预措施
dabigatran 110mg or 150mg
After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)
干预措施: dabigatran (Drug)
ribaroxaban 20mg
After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)
干预措施: ribaroxaban (Drug)
warfarin
After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
干预措施: Warfarin (Drug)
结局指标
主要结局
The changes in reactive hyperemia index (RHI)
时间窗: 12months
次要结局
- right and left mean IMT of the common carotid artery (CCA)(24months)
- right and left maximum IMT of the common carotid artery (CCA)(24months)
- adverse events(24months)
研究者
Weon Kim
professor
Kyunghee University Medical Center