Implementing Precision Medicine Approaches to Guide Anti-platelet Selection Following Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Feasibility of implementing pharmacogenetics to guide antiplatelet therapy
研究概览
简要总结
The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.
详细描述
Study Population:
Adult patients will be eligible for inclusion if they provide informed consent and have no contraindications for 12-months of dual antiplatelet therapy (DAPT).
Baseline Evaluation:
Overview of clinical protocol: Patients with successful PCI will receive a genotype guided recommendation, upon discharge, based on CYP2C19 genotype. Patients who are determined to have CYP2C19 poor metabolizer (PM) or intermediate metabolizer (IM) status will be recommended to receive 12-months of prasugrel. Patients who are determined to have CYP2C19 normal metabolizer (NM), rapid metabolizer (RM), or ultra-rapid metabolizer (UM) phenotype will be recommended to receive a de-escalation treatment, guided by on-treatment platelet reactivity phenotype at 14 days, post discharge.
30-day, 6-month, and 12-month Follow-up: Patients will be contacted by phone or visited during one of their regularly scheduled appointments, at 14 days, 30 days, 6 months , and 12 months, to complete "Follow-up Case Report Forms" to collect outcomes data. The 12-month follow up communication with enrolled patients will end their participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with troponin positive ACS
- •Patients scheduled for left heart catheterization and undergoing PCI
- •Age 18-80 years at time of enrollment
- •Currently receiving or anticipated to receive DAPT, with P2Y12 inhibitor
- •Ability to follow-up for a clinic visit with LAC+USC outpatient cardiology
- •Written informed consent
排除标准
- •Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
- •Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage, and a history of prior transient ischemic attack (TIA) or stroke
- •Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to enrolling in this study. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i. v. catecholamines) for ≥7 days.
- •Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- •Indication for major surgery (per decision of the treating physician) for the planned duration of the study
- •Subject with history of liver transplant or plan to undergo liver transplant during the next 12 months
- •Evidence of significant active neuropsychiatric disease, in the investigator's opinion.
结局指标
主要结局
Feasibility of implementing pharmacogenetics to guide antiplatelet therapy
时间窗: 12 months
The proportion of patients in whom a genetic-guided recommendation is accepted by the clinician
Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy
时间窗: 12 months
The proportion of patients in whom a platelet reactivity phenotype-guided recommendation is accepted by the clinician
次要结局
- Net clinical utility(12 months)
- Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)(12 months)
- Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)(12 months)
- Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)(12 months)
研究者
Scott Mosley, PharmD
Assistant Professor of Clinical Pharmacy
University of Southern California