A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.
研究概览
简要总结
This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has BMI (Body Mass Index) less than 32 kg/m^ 2
- •Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months
- •Subject does not have a history of any bleeding disorder
排除标准
- •Subject is a pregnant or nursing female
- •Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)
- •Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)
- •Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort)
- •Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies
- •Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study
- •Subject regularly uses antacids or other OTC medications (4 or more times per month) for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e.g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years
- •Subject has a history of poor wound healing or a tendency to form keloids
研究组 & 干预措施
Sequence 1
Aspirin - Clopidogrel - Placebo
干预措施: Placebo (to match Aspirin) (Drug)
Sequence 1
Aspirin - Clopidogrel - Placebo
干预措施: Aspirin (Drug)
Sequence 1
Aspirin - Clopidogrel - Placebo
干预措施: Clopidogrel (Drug)
Sequence 2
Clopidogrel - Placebo - Aspirin
干预措施: Placebo (to match Aspirin) (Drug)
Sequence 2
Clopidogrel - Placebo - Aspirin
干预措施: Aspirin (Drug)
Sequence 2
Clopidogrel - Placebo - Aspirin
干预措施: Clopidogrel (Drug)
Sequence 3
Placebo - Aspirin - Clopidogrel
干预措施: Placebo (to match Aspirin) (Drug)
Sequence 3
Placebo - Aspirin - Clopidogrel
干预措施: Aspirin (Drug)
Sequence 3
Placebo - Aspirin - Clopidogrel
干预措施: Clopidogrel (Drug)
Sequence 4
Aspirin - Placebo - Clopidogrel
干预措施: Placebo (to match Aspirin) (Drug)
Sequence 4
Aspirin - Placebo - Clopidogrel
干预措施: Aspirin (Drug)
Sequence 4
Aspirin - Placebo - Clopidogrel
干预措施: Clopidogrel (Drug)
Sequence 5
Clopidogrel - Aspirin - Placebo
干预措施: Placebo (to match Aspirin) (Drug)
Sequence 5
Clopidogrel - Aspirin - Placebo
干预措施: Aspirin (Drug)
Sequence 5
Clopidogrel - Aspirin - Placebo
干预措施: Clopidogrel (Drug)
Sequence 6
Placebo - Clopidogrel - Aspirin
干预措施: Placebo (to match Aspirin) (Drug)
Sequence 6
Placebo - Clopidogrel - Aspirin
干预措施: Aspirin (Drug)
Sequence 6
Placebo - Clopidogrel - Aspirin
干预措施: Clopidogrel (Drug)
结局指标
主要结局
The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.
时间窗: Baseline and 3 days
The intra-subject coefficient of variation of each of the 3 platelet function devices
时间窗: Baseline and 3 days
次要结局
未报告次要终点