Association Between Genetic Variant Scores and Warfarin Effect (AWARE1)

  • STATUS
    Recruiting
  • participants needed
    228
  • sponsor
    Cipherome, Inc.
Updated on 5 October 2022
thrombosis
clot
stroke
warfarin
atrial fibrillation
fibrillation
thrombophilia
deep vein thrombosis
embolism
venous thrombosis
deep venous thrombosis of lower extremity
dvts

Summary

Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥ 4, major bleeding event, ischemic stroke, death) in participants taking warfarin for atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), and/or intracardiac thrombosis.

Description

It is anticipated that next generation genomic sequencing will identify rare genetic variants in ethnically diverse populations, which otherwise would not have been detected using commercially available warfarin tests. Furthermore, retrospective review of clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥ 4, major bleeding event, ischemic stroke) of study participants will determine the clinical utility of genetic variant risk scores. Study outcomes will provide guidance on future directions for optimizing dosing algorithms for warfarin that combine pharmacogenetic principles with clinical dosing.

Details
Condition Atrial Fibrillation, Deep Vein Thrombosis, Intracardiac Thrombus, Pulmonary Embolism, Venous Thromboembolic Disease
Clinical Study IdentifierNCT03894878
SponsorCipherome, Inc.
Last Modified on5 October 2022

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