Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology

Conditions
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Stent Thrombosis, Ischemic Stroke, Myocardial Infarction, Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years and older, who are on P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor). Ability to provide informed consent. Exclusion Criteria: 1. Lack of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADR Group<br>Major Bleeding BARC Bleeding Criteria Type 2,3,5 | |
| Control Group<br>No ADR or treatment failure, case-control matched to experimental groups | |
| Treatment Failure Group<br>Major Adverse Cardiovascular Events (MACE) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the predictive accuracy of Cipherome's drug safety score (DSS) in correlating with serious ADRs in subjects on P2Y12 inhibitors. | 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. | Within 24 months of clopidogrel therapy initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The secondary endpoint is to assess the predictive accuracy of the DSS compared to current evidence-based clinical guidelines, such as CPIC, for serious ADRs (e.g., treatment failure such as MACE) for 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. | The secondary endpoint is to assess the predictive accuracy of the DSS compared to CPIC, for major bleeding per BARC criteria, in subjects on P2Y12 inhibitors. | Within 24 months of clopidogrel therapy initiation |