DOAC ADRs Retrospective Study on Genetic Variations (DARES1)

February 14, 2023 updated by: Cipherome, Inc.

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Santa Clara, California, United States, 95128
        • Santa Clara Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Adverse Drug Reaction on DOAC
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
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
Participants on Direct Oral Anti-coagulants (DOACs) who experience neither major bleeding or treatment failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 1 year of DOAC therapy initiation
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).
Within 1 year of DOAC therapy initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolic events
Time Frame: Within 1 year of DOAC therapy initiation
Thromboembolic events including, but not limited to: deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, arterial thrombosis, or other thromboembolic event
Within 1 year of DOAC therapy initiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovery of novel genetic variants
Time Frame: Within 1 year of DOAC therapy initiation
To discover novel pharmacogenomic variants associated with DOAC metabolism. The investigators will be conducting whole genome sequencing to determine novel variants found in individuals with major bleeding or treatment failures.
Within 1 year of DOAC therapy initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cipherome, Inc.

Collaborators

Santa Clara Valley Medical Center

Investigators

  • Principal Investigator: Dayani Nualles-Percy, MD, Santa Clara Valley Medical Center
  • Study Director: Clifford Wang, MD, Santa Clara Valley Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C02-001 SC003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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