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OpenTrials
Completed

NCT Number: NCT03894878

Association Between Genetic Variant Scores and Warfarin Effect

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, bleeding event, ischemic stroke, death) in participants taking warfarin for atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), and/or intracardiac thrombosis.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Chemically-Induced Disorders Deep Vein Thrombosis Drug-Related Side Effects and Adverse Reactions Embolism Embolism and Thrombosis Heart Diseases Hemorrhage Intracardiac Thrombus Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thromboembolic Disease Venous Thrombosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Clara Valley Medical Center

Santa Clara, California, 95128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-valvular atrial fibrillation
  • Deep venous thrombosis (DVT) and/or pulmonary embolism (PE) with no hypercoagulable condition
  • Non-valvular atrial fibrillation and DVT/PE (with no hypercoagulable condition)
  • Intracardiac thrombosis (i.e. apical thrombosis, atrial thrombosis, auricular thrombosis, mural thrombosis, and/or ventricular thrombosis)
  • Age 18-99 years
  • Signed informed consent

Exclusion criteria

  • Presence of a mechanical heart valve
  • Failure to provide signed informed consent
  • Known diseases that affects coagulation test results such as vitamin K deficiency, disseminated intravascular coagulopathy, Von Willebrand disease, hemophilia, liver failure, etc.

Treatment and study plan

Primary outcomes

  1. Percent time in therapeutic range during initial 12 weeks of warfarin

    Time frame: 12 weeks

    Within the 12 weeks of treatment, this is the percentage of time that a given participant is within the therapeutic range (e.g. participant is in therapeutic range 75% of time/12 weeks of measurement)

Secondary outcomes

  1. Time to reach therapeutic INR

    Time frame: 12 weeks

    Time needed to achieve first INR within the range of 2 to 3, provided that subsequent INR ≥ 7 days later was also within the range of 2 to 3

  2. INR ≥ 4.0 during first 12 weeks of warfarin therapy

    Time frame: 12 weeks

    Time greater than the desired INR therapeutic range within the first 12 weeks of warfarin therapy

  3. Ischemic stroke

    Time frame: 12 weeks

    Development of a clinical diagnosis of an ischemic stroke

  4. Major bleeding event during first 12 weeks of warfarin therapy

    Time frame: 12 weeks

    Development of a major bleeding event during the first 12 weeks of warfarin therapy, diagnosed by a clinician

  5. Clinically relevant non-major bleeding event during the first 12 weeks of warfarin therapy

    Time frame: 12 weeks

    Development of a clinically relevant non-major bleeding event during the first 12 weeks of warfarin therapy, diagnosed by a clinician

Sponsors and collaborators

Lead sponsor

Cipherome, Inc.

Industry

Collaborators

  • Santa Clara Valley Medical Center

Registry information

Official study title

Association Between Risk Scores for Genetic Variants and Percentage of Time in Therapeutic Range for Participants With Atrial Fibrillation, Deep Vein Thrombosis, and/or Intracardiac Thrombosis Taking Warfarin

Acronym: AWARE1

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2019
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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