NCT04247919

DOAC ADRs Retrospective Study

Investigation of Genetic Variations on Patients With Adverse Drug Events While on Direct Oral Anticoagulants (DOACs)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Cipherome, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug-Related Side Effects and Adverse Reactions

Timeline

• Start date: 2020-01-10
• Primary completion: 2020-07-24
• Completion: 2020-07-24
• First posted: 2020-01-30
• Last updated: 2021-03-08

Locations

1 site across 1 country: United States