Clinical trial NCT04580589: DOAC ADRs Retrospective Study on Genetic Variations
Official title: Investigation of Genetic Variations on Patients With Adverse Events While on Direct Oral Anticoagulants (DOACs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-Related Side Effects and Adverse Reactions
Treatment Failure
Lead sponsor: Cipherome, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Santa Clara Valley Medical Center
First posted: 2020-10-08
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Major bleeding event during DOAC therapy
timeFrame: Within 1 year of DOAC therapy initiation
measure: Clinically relevant non-major bleeding
timeFrame: Within 1 year of DOAC therapy initiation
Secondary outcomes:
measure: Thromboembolic events
timeFrame: Within 1 year of DOAC therapy initiation
Other outcomes:
measure: Discovery of novel genetic variants
timeFrame: Within 1 year of DOAC therapy initiation
Locations:
city: Santa Clara
country: United States
facility: Santa Clara Valley Medical Center
state: California
Study officials:
affiliation: Santa Clara Valley Medical Center
name: Dayani Nualles-Percy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Clara Valley Medical Center
name: Clifford Wang, MD
role: STUDY_DIRECTOR
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