CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Flow-mediated Dilation of the Brachial Artery
研究概览
简要总结
CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with percutaneous coronary intervention (PCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •stable coronary disease
- •coronary revascularization with PCI at least 1 month prior to recruitment
排除标准
- •acute coronary syndrome
- •platelet count <70x109/l
- •active bleeding or bleeding diathesis
- •history of intracranial bleeding
- •gastrointestinal bleeding <6 months
- •cerebrovascular accident <3 months
- •history of malignancy
- •concomitant need for oral anticoagulant therapy
- •severe liver disease or chronic renal failure (glomerular filtration rate <30 ml/min /1.73m2)
研究组 & 干预措施
Ticagrelor group
Ticagrelor 90 mg twice daily + standard medical therapy
干预措施: Ticagrelor (Drug)
Ticagrelor group
Ticagrelor 90 mg twice daily + standard medical therapy
干预措施: Standard medical therapy (Drug)
Clopidogrel group
Clopidogrel 150 mg once daily + standard medical therapy
干预措施: Clopidogrel (Drug)
Clopidogrel group
Clopidogrel 150 mg once daily + standard medical therapy
干预措施: Standard medical therapy (Drug)
结局指标
主要结局
Flow-mediated Dilation of the Brachial Artery
时间窗: 4 weeks
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
次要结局
- Platelet Reactivity(4 weeks)
- Endothelium-independent Dilation of the Brachial Artery(4 weeks)
- Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%(4 weeks)
- Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units(4 weeks)
研究者
Germano Di Sciascio
Prof. Germano Di Sciascio
Campus Bio-Medico University