Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects (CARES1)

Cipherome

Status: Completed

Conditions: Ischemic Stroke; Acute Coronary Syndrome; Myocardial Infarction; Stent Thrombosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04580602

C03-001 BD002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

ADR Group

Description:

Major Bleeding BARC Bleeding Criteria Type 2,3,5

Control Group

Description:

No ADR or treatment failure, case-control matched to experimental groups

Treatment Failure Group

Description:

Major Adverse Cardiovascular Events (MACE)