An Open-label, Randomized, Prospective Study Exploring Half Dose of Prasugrel and Ticagrelor in Platelet Response After Acute Coronary Syndromes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
详细描述
In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been strong recommendations for management of patients with ACS undergoing (PCI). These drugs 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
- Single (Outcomes Assessor)
盲法说明
Open-labeled
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 coronary syndrome undergoing primary PCI.
- •Patients receive DAPT (conventional dose of P2Y12 inhibitors+aspirin) at least 1 month.
- •Patients provide written informed consent prior to enrollment.
排除标准
- •Low body weight (<60kg).
- •History of transient ischemic attack or stroke.
- •History of upper gastrointestinal bleeding in recent 6 months.
- •Renal dysfunction defined as serum creatinine > 2.5 mg/dl
- •Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit
- •On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- •Bleeding tendency.
- •Thrombocytopenia defined by platelet < 100,000/ml.
- •Anemia defined by hemoglobin < 10 g/dl.
- •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.
- •Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
- •Contraindication for study drugs.
研究组 & 干预措施
Clopidogrel 75 mg
Clopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose.
干预措施: Clopidogrel 75 mg (Drug)
Prasugrel 5 mg
Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.
干预措施: Prasugrel 5 mg (Drug)
Ticagrelor 45 mg
Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
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 post-PCI 3 months.
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)
次要结局
- Drug side effects(Post-PCI 6 months.)
- Major adverse cardiac and cerebrovascular events (MACCE)(Post-PCI 6 months.)
- Bleeding events(Post-PCI 6 months.)
研究者
Moo Hyun Kim
Professor, Dept. of Cardiology Dong-A University Hospital
Dong-A University