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CARES1: Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects

Sponsor
Cipherome, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04580602
Collaborator
Seoul National University Bundang Hospital (Other)
200
Enrollment
1
Location
24.8
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology
    Actual Study Start Date :
    Oct 7, 2020
    Anticipated Primary Completion Date :
    Oct 28, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    ADR Group

    Major Bleeding BARC Bleeding Criteria Type 2,3,5
    Control Group

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

    Major Adverse Cardiovascular Events (MACE)

    Outcome Measures

    Primary Outcome Measures

    1. To assess the predictive accuracy of Cipherome's drug safety score (DSS) in correlating with serious ADRs in subjects on P2Y12 inhibitors. [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.

    Secondary Outcome Measures

    1. 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]

      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.

    2. 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]

      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.

    Other Outcome Measures

    1. To discover novel pharmacogenetic variants associated with P2Y12 metabolism. [Within 24 months of clopidogrel therapy initiation]

      We will assess the DSS within genes and evaluate the genetic-pathways for P2Y12 metabolism. Novel variants will be assessed using whole genome sequencing to evaluate the genetic pathways in individuals with serious ADRs and treatment failures. Through our analyses we intend to identify novel genetic variants in subjects with serious ADRs or treatment failure while on P2Y12 inhibitors.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SNUBH Seongnam-si Gyonggi-do Korea, Republic of

    Sponsors and Collaborators

    • Cipherome, Inc.
    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Jungwon Suh, MD, SNUBH

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Cipherome, Inc.
    ClinicalTrials.gov Identifier:
    NCT04580602
    Other Study ID Numbers:
    • C03-001 BD002
    First Posted:
    Oct 8, 2020
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ischemic Stroke
    Myocardial Infarction
    Thrombosis
    Acute Coronary Syndrome
    Infarction

    Study Results

    No Results Posted as of Jul 20, 2022