Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Platelet aggregation
研究概览
简要总结
Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients presenting with acute coronary syndrome. Such therapy is started with the administration of a loading dose in patients which are not yet under treatment with P2Y12 inhibitors (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a satisfactory inhibition of platelet aggregation in patients who are already treated with a previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or without a loading starting dose of the newer drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Coronary Syndrome
- •Current dual anti platelet treatment with ASA and Clopidogrel
排除标准
- •No coronary revascularization within the previous six months
- •Ongoing therapy with ticagrelor, prasugrel or ticlopidine before enrollment
- •No treatment with glycoprotein IIb/IIIa inhibitors within the previous 6 days
- •Patients which are known to be no responders to Clopidogrel
- •Known neoplastic or autoimmune disease
- •Liver cirrhosis
- •Severe pulmonary disease
- •Known disorder of Haemostasis
- •Previous Stroke
- •Ongoing pregnancy
- •Therapy with any inhibitor of P450 Cytochrome until 15 days before enrollment
- •Low platelet count or Hb<10 g/dl
研究组 & 干预措施
Group 1 (no loading)
Patients allocated to this group will not receive a loading dose of ticagrelor. In other words, clopidogrel 75 mg/die will be administered until the day before the pharmacological shift (study start), while ticagrelor 90 mg bis in die will be administered from the day of the pharmacological shift on.
干预措施: no loading with Ticagrelor (Drug)
Group 2 (loading)
Patients allocated to this group will receive a loading dose of ticagrelor. In other words, clopidogrel 75 mg/die will be administered until the day before the pharmacological shift (study start). On the very day of the pharmacological shift, patients allocated in Group 2 will receive Ticagrelor 180 mg (loading dose) on the morning and Ticagrelor 90 mg on the evening, while ticagrelor 90 mg bis in die will be administered from the day after the pharmacological shift on.
干预措施: loading with Ticagrelor (Drug)
结局指标
主要结局
Platelet aggregation
时间窗: 2 hours
Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).
次要结局
- 30-days clinical events(30 days)
研究者
Ciro Indolfi
Head of Department (Dipartimento di Scienze Mediche e Chirurgiche)
University Magna Graecia