Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the predictive accuracy of Cipherome's drug safety score (DSS) in correlating with serious ADRs in subjects on P2Y12 inhibitors.
研究概览
简要总结
The goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary insertion who have experienced adverse drug events while on P2Y12 inhibitors.
详细描述
The goal of this study it to validate Cipherome's drug safety score (DSS) in its predictive accuracy for severe adverse drug reactions (ADRs). The DSS is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher chance of an ADR and scores above 0.7 correlated with a lower chance of an ADR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 18 years and older, who are on P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor).
- •Ability to provide informed consent.
排除标准
- •Lack of informed consent
结局指标
主要结局
To assess the predictive accuracy of Cipherome's drug safety score (DSS) in correlating with serious ADRs in subjects on P2Y12 inhibitors.
时间窗: Within 24 months of clopidogrel therapy initiation
The primary endpoint is to assess the predictive accuracy of the DSS compared to actual clinical outcomes of treatment failure (major adverse cardiovascular events or MACE) or bleeding (per BARC criteria) in subjects on P2Y12 inhibitors. The DSS is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher chance of an ADR and scores above 0.7 correlated with a lower chance of an ADR.
次要结局
- To assess the predictive accuracy of the DSS in correlating with serious ADRs compared to clinical guidelines (e.g., Clinical Pharmacogenetics Implementation Consortium (CPIC)) in subjects on P2Y12 inhibitors.(Within 24 months of clopidogrel therapy initiation)
- To assess the predictive accuracy of the DSS in correlating with major bleeding compared to clinical guidelines (CPIC) in subjects on P2Y12 inhibitors.(Within 24 months of clopidogrel therapy initiation)