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Association Between Genetic Variant Scores and DOACs (DARES2)

Sponsor
Cipherome, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04597593
Collaborator
Seoul National University Bundang Hospital (Other)
200
Enrollment
1
Location
26.7
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study's objective is to evaluate the predictive accuracy of Cipherome's algorithm in predicting and preventing serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Bleeding Complication and Treatment Failure of DOAC and Its Predictions Based on Cipherome's Pharmacogenomic Technology
    Actual Study Start Date :
    Oct 7, 2020
    Anticipated Primary Completion Date :
    Dec 29, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    ADR Group

    ISTH bleeding scale Major Bleeding
    Control Group

    No ADR, No Treatment Failure
    Treatment Failure Group

    Recurrent MI, Ischemic stroke, Other thromboembolic disorders

    Outcome Measures

    Primary Outcome Measures

    1. To determine the predictive accuracy of Cipherome's Drug Safety Score (DSS) in correlating with serious Adverse Drug Reactions associated with Direct Oral Anti-coagulants (DOACs) (rivaroxaban, apixaban, dabigatran, and edoxaban). [Within 1 year of DOAC therapy initiation]

      The primary endpoint is to determine the accuracy of the DSS in predicting clinical outcomes of major bleeding per International Society of Thrombosis and Haemostatis (ISTH) criteria in subjects on Direct Oral Anti-coagulants (DOACs). The DSS is calculated on a scale of 0 to 1, with scores below 0.3 correlated with a higher risk of ADRs and scores above 0.7 correlated with a lower risk of ADRs. We will determine the DSS of all subjects who experienced major bleeding and compare it to the DSS of control subjects who did not experience bleeding.

    Secondary Outcome Measures

    1. To evaluate the predictive accuracy of the DSS in correlating with serious ADRs compared to clinical tools (e.g., HAS BLED criteria). [Within 1 year of DOAC therapy initiation]

      The secondary endpoint is to determine the accuracy of the DSS predicting clinical outcomes compared to clinical tools such as the HAS-BLED scoring system. A subject with a HAS-BLED score of > 4 points will be considered moderate-high risk of bleeding and a HAS-BLED score of 4 or less will be considered low risk. A DSS is calculated on a scale of 0 to 1, with scores below 0.3 correlated with a higher risk of ADRs and scores above 0.7 correlated with a lower risk of ADRs. Both DSS (low and high risk subjects) and HAS-BLED scores (low and high risk subjects) will be compared to actual clinical outcomes to assess the predictive accuracy of each scoring system.

    2. To evaluate the predictive accuracy of the DSS in correlating with treatment failures while on Direct Oral Anti-coagulants (DOACs) [Within 1 year of DOAC therapy initiation]

      The secondary endpoint is to determine the accuracy of the DSS in predicting treatment failures (e.g., recurrent MI, systemic embolism, or ischemic stroke) as compared to clinical outcomes while on DOACs. The DSS is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher risk of ADRs and scores above 0.7 correlated with a lower risk of ADRs.

    Other Outcome Measures

    1. To discover novel pharmacogenetic variants associated with Direct Oral Anti-coagulants (DOACs) [Within 1 year of DOAC therapy initiation]

      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:
    • Any adult patient 18 years and older, who experienced a serious adverse drug reaction while taking a DOAC and is able to provide informed consent.
    Exclusion Criteria:
    • Failure to provide 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: Ilyoung Oh, MD, SNUBH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cipherome, Inc.
    ClinicalTrials.gov Identifier:
    NCT04597593
    Other Study ID Numbers:
    • C02-002 BD001
    First Posted:
    Oct 22, 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:
    Iatrogenic Disease
    Drug-Related Side Effects and Adverse Reactions

    Study Results

    No Results Posted as of Jul 20, 2022