DOAC ADRs Retrospective Study

Terminated

• Conditions: Drug-Related Side Effects and Adverse Reactions

• Registration Number: NCT04247919
• Lead Sponsor: Cipherome, Inc.

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.

Study Timeline

• Study Start: 2020-01-10
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Primary Completion: 2020-07-24
• Study Completion: 2020-07-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

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Exclusion Criteria

• Failure to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Deaths Reported	Through study completion, an average of 1 year	Death at any time
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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States