Clinical trial NCT04580602: Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects
Official title: Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stent Thrombosis
Ischemic Stroke
Myocardial Infarction
Acute Coronary Syndrome
Lead sponsor: Cipherome, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2020-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects (status post myocardial infarction and percutaneous coronary insertion) who have experienced adverse drug events while on P2Y12 inhibitors in order to improve future prediction and prevention of adverse events.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years and older, who are on P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor).
2. Ability to provide informed consent.

Exclusion Criteria:

1. Lack of informed consent

Primary outcomes:
measure: To assess the predictive accuracy of Cipherome's drug safety score (DSS) in correlating with serious ADRs in subjects on P2Y12 inhibitors.
timeFrame: Within 24 months of clopidogrel therapy initiation
Secondary outcomes:
measure: 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.
timeFrame: Within 24 months of clopidogrel therapy initiation
measure: To assess the predictive accuracy of the DSS in correlating with major bleeding compared to clinical guidelines (CPIC) in subjects on P2Y12 inhibitors.
timeFrame: Within 24 months of clopidogrel therapy initiation
Other outcomes:
measure: To discover novel pharmacogenetic variants associated with P2Y12 metabolism.
timeFrame: Within 24 months of clopidogrel therapy initiation
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: SNUBH
state: Gyonggi-do
Study officials:
affiliation: SNUBH
name: Jungwon Suh, MD
role: PRINCIPAL_INVESTIGATOR
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