Clinical trial NCT04247919: DOAC ADRs Retrospective Study
Official title: Investigation of Genetic Variations on Patients With Adverse Drug Events While on Direct Oral Anticoagulants (DOACs)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Drug-Related Side Effects and Adverse Reactions
Lead sponsor: Cipherome, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Santa Clara Valley Medical Center
First posted: 2020-01-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients on rivaroxaban, apixaban, and dabigatran who experienced a serious adverse drug reaction and/or treatment failure.

Brief summary: This retrospective study's objective is to evaluate if Cipherome's algorithm could have predicted the serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).

Detailed description: Using the latest next generation sequencing tools, this study will evaluate adverse drug reactions (ADRs) (e.g., major bleeding or treatment failure) in study participants while on direct oral anticoagulants (DOACs). A web-based program will analyze the data obtain from sequencing, and generate a drug safety score (DSS). The DSS risk score will be compared with pre-specified serious ADRs associated with DOAC therapy. A secondary analysis will involve discovery of novel variants that arise from our analysis and may potentially affect the outcome of DOAC treatment.

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: Number of Participants with a Major Bleeding Event
timeFrame: Within 90 days of DOAC therapy initiation
measure: Number of Participants with a Clinically Relevant Non-major Bleeding Event
timeFrame: Within 90 days of DOAC therapy initiation
measure: Number of Deaths Reported
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Participants with a Thromboembolic Event
timeFrame: Within 90 days of DOAC therapy initiation
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
Study officials:
affiliation: Santa Clara Valley Medical Center
name: Clifford Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Clara Valley Medical Center
name: Michelle Wilson, MD
role: STUDY_DIRECTOR
affiliation: Santa Clara Valley Medical Center
name: Jessica Song, PharmD
role: STUDY_DIRECTOR
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