IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Change in prescription of antiplatelet therapy
研究概览
简要总结
Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).
详细描述
The study will randomize patients who have completed PCI and who are prescribed dual antiplatelet therapy to a genotype guided arm, in which CYP2C19 pharmacogenetic testing will be performed and a standard therapy arm without genetic testing. The study will examine the impact of pharmacogenetic testing on physician medication choice and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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 with ischemic heart disease, who are prescribed dual antiplatelet therapy after percutaneous coronary intervention (PCI). Enrollment has to occur during index hospitalization or during outpatient visit for cath lab procedure.
排除标准
- •Pregnant or breastfeeding.
- •Unwilling or unable, in the opinion of the investigator, to comply with instructions on prescribed medicines.
- •Prior known allergy or intolerance to clopidogrel.
研究组 & 干预措施
Pharmacogenetic Results Available to Provider
Genotyping for CYP2C19 variants is performed. The test results are integrated into the electronic health record and alerts are displayed to the prescriber. The ultimate decision regarding antiplatelet therapy is left to the prescriber
干预措施: Prescriber Access to Genetic Information (Other)
Control Arm
No genotyping information is performed as part of clinical care. Standard therapy is followed. Genotyping will be performed at conclusion of study in control arm, and genotyping results will not be incorporated into electronic health record.
结局指标
主要结局
Change in prescription of antiplatelet therapy
时间窗: one year
Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up
次要结局
- Urgent target vessel revascularization(one year)
- Stent Thrombosis(one year)
- Major and Minor Bleeding(one year)
- Death, Myocardial Infarction, Stroke(one year)
研究者
Rolf Kreutz
MD. Associate Professor of Clinical Medicine
Indiana University