Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Platelet reactivity
研究概览
简要总结
To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.
详细描述
Consist with previous study Ticagrelor had greater, faster and more the platelet inhibition effect than Clopidogrel in both healthy subjects and stable coronary artery disease patients. Moreover, Asian subjects exposed higher active metabolite and stronger pharmacodynamics response than European subjects with same oral dose of antiplatelet agent. However, previous report comparing the efficacy and safety of Ticagrelor and Clopidogrel in healthy Asian ethnicity is lacking. Therefore, the aim of this study is to evaluate the pharmacodynamic responses of a lower Ticagrelor dose using laboratory platelet function tests in healthy Korean volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •12 healthy men
- •Aged between 19 and 59 years
- •Body mass index (BMI) is between 18.5 and 29.9 kg/m2
- •Baseline maximal platelet aggregation (MPA) 10 μmol/L ADP is more than 65%
- •To screen for standard results on usual clinical tests
排除标准
- •A history of bleeding within 6 months
- •Bleeding diathesis
- •Hemoglobin < 12g/dl
- •History of antiplatelet or anticoagulation treatment within 1 month
- •contraindication to the study drug
- •Severe hepatic dysfunction (serum liver enzyme or bilirubin >3 times normal limit)
- •Patients with hereditary disease such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption
- •Previous experience of clinical trials within three months
研究组 & 干预措施
Ticagrelor 90 mg
The subjects administer Ticagrelor 90 mg as loading dose (LD) follow by 90 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Clopidogrel 600 mg as LD follow by 75 mg/day as MD for 5 days).
干预措施: Ticagrelor 90 mg (Drug)
Clopidogrel 600 mg
The subjects administer Clopidogrel 600 as loading dose (LD) follow by 75 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Ticagrelor 90 mg/day as LD, follow by 90 mg/day as MD for 5 days).
干预措施: Clopidogrel 600 mg (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: up to 122 hours
Platelet reactivity will be measured using multiple platelet function tests, including, light transmission aggregometry (LTA), multiple electrode platelet aggregometry (MEA, Dynabyte Medical, Munich, Germany), VerifyNow (Accumetrics, San Diego, CA, USA), Total thrombus-formation analysis system (T-TAS®, Fujimori Kogyo, Japan). The platelet reactivity will be measured at 0.5, 2, 6, 24,26,120,122 hours after study drug administration. Percent inhibition is calculated using the following formula: % inhibition =\[(baseline reactivity unit - gain(t) reactivity unit) / baseline reactivity unit\] × 100. * Baseline reactivity unit is the value before Ticagrelor or Clopidogrel loading dose. * Gain(t) reactivity unit is the value for each subject at selected time points ( 0.5, 2, 6, 24,26,120,122 hours after study drug administration).
次要结局
未报告次要终点
研究者
Moo Hyun Kim
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital
Dong-A University