EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 3
- 主要终点
- Number of cells
研究概览
简要总结
Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).
详细描述
ACS Patients in both treatment groups will be assessed:
Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign Informed Consent Form
- •18 yr or older
- •Male and female (post menopause or contraception treatment)
- •ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
- •Planned invasive strategy (coronariography performed within 72hrs after admission)
排除标准
- •Aspirin, clopidogrel or ticagrelor allergy.
- •Hemorrhagic diathesis or very high risk of bleeding.
- •Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
- •Limited life expectancy.
- •Elective surgery planned.
- •High chance of not being able to complete the follow-up period.
研究组 & 干预措施
Ticagrelor
180mg initial dose next day 90mg BID
干预措施: Ticagrelor vs Clopidogrel (Drug)
Clopidogrel
600mg po initial dose and 75mg qd starting next day
干预措施: Ticagrelor vs Clopidogrel (Drug)
结局指标
主要结局
Number of cells
时间窗: 1 month visit
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
次要结局
- Platelet reactivity(1 month visit)