A Randomized, Open-label, Pharmacodynamic and Pharmacokinetic Trial Assessing the Effect of Lowering Ticagrelor Maintenance Dose Early After Myocardial Infarction on Platelet Inhibition (ELECTRA Pilot Study).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Platelet Reactivity Assessed with the VASP assay
研究概览
简要总结
The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet inhibition in stable patients who recently underwent acute myocardial infarction and were treated with percutaneous coronary intervention.
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
- Single (Outcomes Assessor)
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
- •provision of informed consent prior to any study specific procedures
- •diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction according to the Third Universal Definition of Myocardial Infarction
- •index event treatment with percutaneous coronary intervention
- •male or non-pregnant female, aged 18-80 years old
排除标准
- •contraindications for ticagrelor
- •further coronary revascularization planned during the first 45 days after myocardial infarction
- •indications for chronic treatment with oral anticoagulant or low-molecular-weight heparin
- •active bleeding
- •history of intracranial hemorrhage
- •recent gastrointestinal bleeding (within 30 days)
- •history of coagulation disorders
- •history of moderate or severe hepatic impairment
- •history of major surgery or severe trauma (within 3 months)
- •active neoplastic disease
- •patient requiring dialysis
- •chronic inflammatory disease
- •current therapy with strong CYP3A inhibitors or strong CYP3A inducers
研究组 & 干预措施
Standard ticagrelor maintenance dose
Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.
干预措施: Ticagrelor 90 mg (Drug)
Reduced ticagrelor maintenance dose
Ticagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days.
干预措施: Ticagrelor 90 mg (Drug)
Reduced ticagrelor maintenance dose
Ticagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days.
干预措施: Ticagrelor 60 mg (Drug)
结局指标
主要结局
Platelet Reactivity Assessed with the VASP assay
时间窗: 45 days
Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.
次要结局
- Number of Patients With High Platelet Reactivity according to the VASP assay(45 days)
- Plasma concentration of Ticagrelor(45 days)
- Plasma concentration of AR-C124910XX(45 days)
- Platelet Reactivity Assessed with Multiple Electrode Aggregometry(45 days)
- Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry(45 days)
研究者
Jacek Kubica
Prof. Jacek Kubica, MD, PhD
Collegium Medicum w Bydgoszczy