DOAC ADRs Retrospective Study

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04247919

Enrollment

Registered

2020-01-30

Start date

2020-01-10

Completion date

2020-07-24

Last updated

2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with a Major Bleeding Event	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
Number of Participants with a Clinically Relevant Non-major Bleeding Event	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).
Number of Deaths Reported	Through study completion, an average of 1 year	Death at any time

Secondary

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

Countries

United States

Outcome results