The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Optimal platelet reactivity (OPR) rate
研究概览
简要总结
East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).
详细描述
In recent years, newer oral P2Y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with AMI undergoing (PCI). This drug provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients present with acute myocardial infarction undergoing PCI.
- •Patients receiving ticagrelor; Male or female gender; Age 20-75 years.
- •Patients provide written informed consent prior to enrollment.
排除标准
- •Low body weight (<60kg).
- •History of hemorrhagic stroke.
- •History of upper gastrointestinal bleeding in recent 6 months.
- •Bleeding tendency.
- •Thrombocytopenia defined by platelet < 100,000/ml.
- •Anemia defined by hemoglobin < 10 g/dl.
- •Renal dysfunction defined as serum creatinine > 2.5 mg/dl.
- •Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit.
- •Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
- •Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
研究组 & 干预措施
Control group
Clopidogrel 75 mg/day as maintenance dose
干预措施: Clopidogrel 75 mg (Drug)
Treatment group 1
De-escalation strategy dose receive ticagrelor 60 mg twice daily
干预措施: Ticagrelor 60mg (Drug)
Treatment group 2
De-escalation strategy dose receive ticagrelor 45 mg twice daily
干预措施: Ticagrelor 45 mg (Drug)
结局指标
主要结局
Optimal platelet reactivity (OPR) rate
时间窗: At 1 month
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)
次要结局
- Major adverse cardiac and cerebrovascular events (MACCE)(At 9 months)
- Bleeding events(At 9 months.)
研究者
Moo Hyun Kim
Professor, Dept. of Cardiology Dong-A University Hospital
Dong-A University