The Effect of Inducing the Cytochrome P450 System on the Pharmacodynamic Efficacy of Clopidogrel
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean platelet reactivity (as measured in platelet reactivity units) on day 7 and day 21
研究概览
简要总结
The purpose of this study is to evaluate whether patients post PCI receiving clopidogrel who are carriers of at least one CYP 2C19 loss-of-function allele may achieve improved pharmacodynamic efficacy of clopidogrel when treated with the CYP 2C19 enzyme inducing agent, St. John's wort, as compared with placebo.
Hypothesis
- Reduced platelet reactivity is present in patients receiving St. John's wort as compared to placebo when utilized in combination with clopidogrel
- The combination or St. John's wort and clopidogrel results in enhanced platelet inhibition
详细描述
Objective The purpose of this study is to evaluate whether patients post PCI receiving clopidogrel who are carriers of at least one CYP 2C19 loss-of-function allele may achieve improved pharmacodynamic efficacy of clopidogrel when treated with the CYP 2C19 enzyme inducing agent, St. John's wort, as compared with placebo.
Specific Aims
- To identify the difference in platelet reactivity in patients receiving St. John's wort or placebo
- To characterize the difference in platelet inhibition in patients receiving St. John's wort or placebo
Hypothesis
- Reduced platelet reactivity is present in patients receiving St. John's wort as compared to placebo when utilized in combination with clopidogrel
- The combination or St. John's wort and clopidogrel results in enhanced platelet inhibition
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 or older
- •Patients with a history of ACS and/or who receive PCI with stent placement at Lancaster General Hospital requiring dual antiplatelet therapy with aspirin and clopidogrel.
排除标准
- •Patients with active or any known history of bleeding such as gastrointestinal, intracranial, or any other bleeding diathesis
- •History of major surgery in the last year (any surgical procedure that involves general anesthesia or respiratory assistance)
- •Clinical findings associated with an increased risk of bleeding at the judgment of the investigator
- •Patients actively receiving anticoagulation therapy
- •Hemoglobin < 10 g/dL
- •Platelets < 150,000/mm3
- •Known hepatic dysfunction
- •History of intracranial malignancy or stroke
- •Patients receiving thienopyridines chronically prior to PCI
- •Concurrent use of CYP P450 2C19 substrates, or inhibiting/ inducing medications with the exception of proton pump inhibitors
- •Illicit drug or alcohol abuse
- •Daily treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors
- •Allergy to St. Johns wort or lactose
- •Patients expected to discontinue dual antiplatelet therapy prior to completion of the study protocol
- •Patients unable to adhere to the study protocol
研究组 & 干预措施
AB: Placebo (A); St. Johns Wort (B)
Receive placebo for 7 days, 7 days washout and 7 days of St. Johns Wort
干预措施: Placebo (Drug)
AB: Placebo (A); St. Johns Wort (B)
Receive placebo for 7 days, 7 days washout and 7 days of St. Johns Wort
干预措施: St. Johns Wort (Drug)
BA: St. Johns Wort (B); Placebo (A)
Receive St. Johns Wort for 7 days, 7 days washout and 7 days of placebo
干预措施: Placebo (Drug)
BA: St. Johns Wort (B); Placebo (A)
Receive St. Johns Wort for 7 days, 7 days washout and 7 days of placebo
干预措施: St. Johns Wort (Drug)
结局指标
主要结局
Mean platelet reactivity (as measured in platelet reactivity units) on day 7 and day 21
时间窗: Day 7 and Day 21
The investigators are comparing the mean platelet reactivity (as measured in platelet reactivity units) within subjects (treatment effect) between placebo and St. Johns Wort. In addition we will be assessing the period effect (difference between those getting treatment AB - placebo/St. Johns Wort and those getting treatment BA - St. Johns Wort/placebo).
次要结局
未报告次要终点
研究者
Michael A. Horst, PhD, MPHS, MS
Director of Research
Lancaster General Hospital