NCT04580589

DOAC ADRs Retrospective Study on Genetic Variations

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Cipherome, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug-Related Side Effects and Adverse Reactions
• Treatment Failure

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2020-10-08
• Last updated: 2023-02-16

Locations

1 site across 1 country: United States