DOAC ADRs Retrospective Study on Genetic Variations (DARES1)

Cipherome

Status: Completed

Conditions: Treatment Failure; Drug-Related Side Effects and Adverse Reactions

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04580589

C02-001 SC003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

210 participants in 3 patient groups

Adverse Drug Reaction on DOAC

Description:

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

Description:

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

Description:

Participants on Direct Oral Anti-coagulants (DOACs) who experience neither major bleeding or treatment failure.