Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants With High Platelet Reactivity
研究概览
简要总结
To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
详细描述
Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ST-segment elevation myocardial infarction
- •Undergoing primary percutaneous coronary intervention
- •Aged between 20 and 80 years
排除标准
- •Previous administration of any antagonist of the platelet adenosine diphosphate (ADP) P2Y12 receptor (clopidogrel, prasugrel or ticagrelor)
- •History of stroke or transient ischemic attack
- •Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count < 100,000/mm3 or hemoglobin < 10 g/dl
- •Chronic oral anticoagulation treatment
- •Contraindication to the antiplatelet treatment
- •Severe renal insufficiency (serum creatine>2.5 mg/dl)
- •Severe hepatic dysfunction (serum liver enzyme or bilirubin>3 times normal limit)
- •Sever chronic obstructive pulmonary disease (COPD) or bradycardia
- •Body weight < 50 kg
研究组 & 干预措施
Prasugrel 60 mg
Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose
干预措施: Prasugrel 60 mg (Drug)
Ticagrelor 180 mg
Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
干预措施: Ticagrelor 180 mg (Drug)
结局指标
主要结局
Number of Participants With High Platelet Reactivity
时间窗: 48 hours after loading dose of study drug
Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%.
次要结局
- Major Adverse Cardiac and Cerebrovascular Events(30 days)
- Bleeding Event(30 days)
- Adverse Drug Reaction(30 days)
- Pre-procedure P2Y12 Reaction Units (PRU)(Baseline)
- Number of Participants With Low Platelet Reactivity(48 hours after loading dose of study drug)
- Pre-procedure Platelet Reactivity Index (PRI)(Baseline)
研究者
Moo Hyun Kim
M.D. Director, Global Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital
Dong-A University