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DOAC ADRs Retrospective Study on Genetic Variations (DARES1)

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ClinicalTrials.gov Identifier: NCT04580589
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : September 20, 2021
Sponsor:
Collaborator:
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Cipherome, Inc.

Study Description
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Brief Summary:
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.

Condition or disease
Drug-Related Side Effects and Adverse Reactions Treatment Failure

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Investigation of Genetic Variations on Patients With Adverse Events While on Direct Oral Anticoagulants (DOACs)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Groups and Cohorts
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Group/Cohort
Adverse Drug Reaction on DOAC
Participants on Direct Oral Anti-coagulants (DOACs) who experience major bleeding or clinically relevant non-major bleeding per International Society of Thrombosis and Haemostasis criteria. This is an observational study, so there will be no intervention.
Treatment Failure on DOAC
Participants on Direct Oral Anti-coagulants (DOACs) who experience treatment failure (e.g., recurrent MI, systemic embolism, ischemic stroke, etc.). This is an observational study, so there will be no intervention.
Case Control
Participants on Direct Oral Anti-coagulants (DOACs) who experience neither major bleeding or treatment failure.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Blood DNA sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580589


Contacts
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Contact: Kenneth J Park, PharmD 8175040116 kenneth.park@cipherome.com
Contact: Jane Chiang, MD 4082431460 ext 1007 jane.chiang@cipherome.com

Locations
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United States, California
Santa Clara Valley Medical Center Recruiting
Santa Clara, California, United States, 95128
Contact: Dayani Nualles-Percy, MD    669-287-9206    Dayani.NuallesPercy@hhs.sccgov.org   
Contact: Clifford Wang, MD    (408) 885-5000    Clifford.wang@hhs.sccgov.org   
Sponsors and Collaborators
Cipherome, Inc.
Santa Clara Valley Medical Center
Investigators
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Principal Investigator: Dayani Nualles-Percy, MD Santa Clara Valley Medical Center
Study Director: Clifford Wang, MD Santa Clara Valley Medical Center
Study Director: Jessica Song, PharmD Santa Clara Valley Medical Center
More Information
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Publications:

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Responsible Party: Cipherome, Inc.
ClinicalTrials.gov Identifier: NCT04580589    
Other Study ID Numbers: C02-001 SC003
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders