Investigation of Genetic Variations on Patients With Adverse Events While on Direct Oral Anticoagulants (DOACs)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cipherome, Inc.
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Major bleeding event during DOAC therapy
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Major bleeding event during DOAC therapy
Time Frame: Within 1 year of DOAC therapy initiation
* Reduction in hemoglobin of at least 2 g/dL * Blood loss requiring transfusion of at least 2 units of whole blood or erythrocytes * Critical anatomical sites of bleeding: intramuscular with compartment syndrome, intracranial, intraspinal, retroperitoneal, intraocular, pericardial, and atraumatic intra-articular bleeding. * Bleeding leading to death
Clinically relevant non-major bleeding
Time Frame: Within 1 year of DOAC therapy initiation
* Hospital admission for bleeding, or * Physician guided medical or surgical treatment for bleeding, or * Change in antithrombotic therapy (including interruption or discontinuation of study drug).
Secondary Outcomes
- Thromboembolic events(Within 1 year of DOAC therapy initiation)