Association Between Genetic Variant Scores and DOACs (DARES2)

Cipherome

Status: Completed

Conditions: Drug-Related Side Effects and Adverse Reactions; Iatrogenic Disorder

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04597593

C02-002 BD001

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

ADR Group

Description:

ISTH bleeding scale Major Bleeding

Control Group

Description:

No ADR, No Treatment Failure

Treatment Failure Group

Description:

Recurrent MI, Ischemic stroke, Other thromboembolic disorders