DOAC ADRs Retrospective Study

March 4, 2021 updated by: Cipherome, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Jose, 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

All patients on rivaroxaban, apixaban, and dabigatran who experienced a serious adverse drug reaction and/or treatment failure.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a Major Bleeding Event
Time Frame: Within 90 days 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 led to death
Within 90 days of DOAC therapy initiation
Number of Participants with a Clinically Relevant Non-major Bleeding Event
Time Frame: Within 90 days of DOAC therapy initiation

Acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following:

A hospital admission for bleeding, or A physician guided medical or surgical treatment for bleeding, or A change in antithrombotic therapy (including interruption or discontinuation of study drug).
Within 90 days of DOAC therapy initiation
Number of Deaths Reported
Time Frame: Through study completion, an average of 1 year
Death at any time
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a Thromboembolic Event
Time Frame: Within 90 days of DOAC therapy initiation
Deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, arterial thrombosis, or other thromboembolic event.
Within 90 days 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

  • Study Director: Jessica Song, PharmD, Santa Clara Valley Medical Center
  • Principal Investigator: Clifford Wang, MD, Santa Clara Valley Medical Center
  • Study Director: Michelle Wilson, 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)

January 10, 2020

Primary Completion (Actual)

July 24, 2020

Study Completion (Actual)

July 24, 2020

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C02-001 SC002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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