Effect of Cilostazol as an add-on Treatment to a Single Antiplatelet Agent (Acetylsalicylic Acid or Clopidogrel) on Platelet Function Testing and Bleeding Time in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Ex-vivo Inhibition Of Platelet Aggregation (IPA)
研究概览
简要总结
The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian male subjects
- •Able to read, to write and to fully understand German language
- •Provision of written informed consent before screening and baseline
- •BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
- •Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
排除标准
- •Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
- •Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
- •Use of antibiotics within thirty (30) days prior to screening and until baseline visit
- •Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
- •Supine pulse rate > 100 beats/min or <50 beats/min
- •Systolic blood pressure <100 or >140 mmHg
- •Diastolic blood pressure <50 or >90 mmHg
- •Concomitant use of any other medication including over-the-counter preparations
研究组 & 干预措施
Group 1 (CYP2C19 Wild Type)
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Acetylsalicylic acid 100 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Acetylsalicylic acid 100mg once daily for 1 week (Days 22-28)
干预措施: Cilostazol (Drug)
Group 1 (CYP2C19 Wild Type)
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Acetylsalicylic acid 100 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Acetylsalicylic acid 100mg once daily for 1 week (Days 22-28)
干预措施: Acetylsalicylic acid (Drug)
Group 2 (CYP2C19 Wild Type)
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
干预措施: Cilostazol (Drug)
Group 2 (CYP2C19 Wild Type)
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
干预措施: Clopidogrel (Drug)
Group 3 (CYP2C19 heterozygous (*1/*2) )
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
干预措施: Cilostazol (Drug)
Group 3 (CYP2C19 heterozygous (*1/*2) )
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
干预措施: Clopidogrel (Drug)
Group 4 (CYP2C19 homozygous (*2/*2))
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
干预措施: Cilostazol (Drug)
Group 4 (CYP2C19 homozygous (*2/*2))
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Ex-vivo Inhibition Of Platelet Aggregation (IPA)
时间窗: Baseline, Visit 5 (Day 22-29)
The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on IPA was determined ex vivo in citrated platelet rich plasma (PRP) after stimulation of aggregation by low-level adenosine diphosphate (ADP) (5 micromolar \[uM\]) and arachidonic acid (AA) (500 milligrams/liter \[mg/L\]). Light transmission aggregometry (LTA) was used to measure residual aggregation (the percentage of aggregation 5 minutes after the addition of ADP or AA). Results are reported as the 95% confidence intervals for the reported geometric mean ratios (GMRs) (\[cilostazol+reference (ASA or clopidogrel)\]/reference) for IPA.
次要结局
- Effects On Skin Bleeding Time (BT)(Visit 5 (Day 22-29))