Clinical trial NCT04597593: Association Between Genetic Variant Scores and DOACs (DARES2)
Official title: Correlation Between Bleeding Complication and Treatment Failure of DOAC and Its Predictions Based on Cipherome's Pharmacogenomic Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-Related Side Effects and Adverse Reactions
Iatrogenic Disorder
Lead sponsor: Cipherome, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients on rivaroxaban, apixaban, dabigatran, and edoxaban who experienced a serious adverse drug reaction and/or treatment failure and case-matched controls.

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Within 1 year of DOAC therapy initiation
Secondary outcomes:
measure: To evaluate the predictive accuracy of the DSS in correlating with serious ADRs compared to clinical tools (e.g., HAS BLED criteria).
timeFrame: Within 1 year of DOAC therapy initiation
measure: To evaluate the predictive accuracy of the DSS in correlating with treatment failures while on Direct Oral Anti-coagulants (DOACs)
timeFrame: Within 1 year of DOAC therapy initiation
Other outcomes:
measure: To discover novel pharmacogenetic variants associated with Direct Oral Anti-coagulants (DOACs)
timeFrame: Within 1 year of DOAC therapy initiation
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: SNUBH
state: Gyonggi-do
Study officials:
affiliation: SNUBH
name: Ilyoung Oh, MD
role: PRINCIPAL_INVESTIGATOR
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