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Completed

NCT Number: NCT04580589

DOAC ADRs Retrospective Study on Genetic Variations

The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots from forming in the blood vessels.

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Key information

Conditions

Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Treatment Failure

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Clara Valley Medical Center

Santa Clara, California, 95128, United States

About this study

Genes can have variants or mutations that can increase the participant's risk for bleeding when receiving a direct oral anticoagulant (DOACs). The investigators will be studying participants on DOACs who have had bleeding and also participants who are on DOACs who did not have bleeding (control group). The goal of the study is to determine the accuracy of Cipherome's Drug Safety Score (DSS) in it's ability to predict adverse drug reactions (ADRs). A DSS score ranges from 0 to 1, with scores less than 0.3 correlated with a higher risk of ADRs and scores more than 0.7 correlated with a lower risk of ADRs. The participant's DSS score will be compared with the actual clinical outcome using a statistical test to determine the accuracy of the DSS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any adult patient 18 years and older, who experienced major bleeding, clinically relevant non major bleeding or treatment failure while taking a DOAC during the study time frame and is able to provide informed consent. Control patients will be recruited from all adult patients who are on DOAC therapy.

Exclusion criteria

  • Failure to provide informed consent

Treatment and study plan

Primary outcomes

  1. Major bleeding event during DOAC therapy

    Time frame: Within 1 year of DOAC therapy initiation

    • Reduction in hemoglobin of at least 2 g/dL
    • Blood loss requiring transfusion of at least 2 units of whole blood or erythrocytes
    • Critical anatomical sites of bleeding: intramuscular with compartment syndrome, intracranial, intraspinal, retroperitoneal, intraocular, pericardial, and atraumatic intra-articular bleeding.
    • Bleeding leading to death

  2. Clinically relevant non-major bleeding

    Time frame: Within 1 year of DOAC therapy initiation

    • Hospital admission for bleeding, or
    • Physician guided medical or surgical treatment for bleeding, or
    • Change in antithrombotic therapy (including interruption or discontinuation of study drug).

Secondary outcomes

  1. Thromboembolic events

    Time frame: Within 1 year of DOAC therapy initiation

    Thromboembolic events including, but not limited to: deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, arterial thrombosis, or other thromboembolic event

Other outcomes

  1. Discovery of novel genetic variants

    Time frame: Within 1 year of DOAC therapy initiation

    To discover novel pharmacogenomic variants associated with DOAC metabolism. The investigators will be conducting whole genome sequencing to determine novel variants found in individuals with major bleeding or treatment failures.

Sponsors and collaborators

Lead sponsor

Cipherome, Inc.

Industry

Collaborators

  • Santa Clara Valley Medical Center

Registry information

Official study title

Investigation of Genetic Variations on Patients With Adverse Events While on Direct Oral Anticoagulants (DOACs)

Acronym: DARES1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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