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Association Between Genetic Variant Scores and Warfarin Effect (AWARE1)

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ClinicalTrials.gov Identifier: NCT03894878
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Cipherome, Inc.

Study Description
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Brief 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.

Condition or disease
Atrial Fibrillation Deep Vein Thrombosis Intracardiac Thrombus Pulmonary Embolism Venous Thromboembolic Disease

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : April 29, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA

Sample collection:

One 3 mL venous blood sample will be taken from each study participant and collected in EDTA tubes on the day of the one-time study visit, when the participant is reporting to the SCVH&HS laboratory to undergo INR testing per Anticoagulation Clinic protocol.

This 3 mL venous blood sample will be taken from each study participant, in addition to the standard of care blood draw for INR. Each sample tube will be labeled with the protocol study number, along with the date and time of collection.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Participants with a known disease that predisposes them to bleeding will be excluded, since it will be a confounder (trying to link abnormal genetic variant risk score to bleeding).
  2. Participants taking medications or on a diet that increases bleeding propensity will also be excluded.
  3. Pediatric participants will be excluded from this study, since atrial fibrillation and/or venous thromboembolism are rare in this cohort.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of a mechanical heart valve
  2. Failure to provide signed informed consent
  3. Known diseases that affects coagulation test results such as vitamin K deficiency, disseminated intravascular coagulopathy, Von Willebrand disease, hemophilia, liver failure, etc.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894878


Contacts
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Contact: Kenneth J Park, PharmD 817-504-0116 kenneth.park@cipherome.com
Contact: Jane Chiang, MD (408) 243-1460 ext 1007 jane.chiang@cipherome.com

Locations
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United States, California
Santa Clara Valley Medical Center Recruiting
Santa Clara, California, United States, 95128
Contact: Clifford Wang, MD    408-885-5000    Clifford.Wang@hhs.sccgov.org   
Contact: Dayani Nualles-Percy, MD    (669) 287-9206    Dayani.NuallesPercy@hhs.sccgov.org   
Sponsors and Collaborators
Cipherome, Inc.
Santa Clara Valley Medical Center
Investigators
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Principal Investigator: Clifford Wang, MD Santa Clara Valley Medical Center
Study Director: Jessica Song, PharmD Santa Clara Valley Medical Center
Study Director: Dayani Nualles-Percy, MD Santa Clara Valley Medical Center
More Information
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Publications:
https://www.bcbsks.com/CustomerService/Providers/MedicalPolicies/policies/policies/GeneticTesting_WarfarinDose_2017-09-01.pdf (Accessed July 22, 2019)

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Responsible Party: Cipherome, Inc.
ClinicalTrials.gov Identifier: NCT03894878    
Other Study ID Numbers: C01-001 SC001
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cipherome, Inc.:
Warfarin
Coumadin
Pharmacogenomics
 Pharmacogenetics
Adverse Drug Reactions
Bleeding/hemorrhaging
Additional relevant MeSH terms:
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Pulmonary Embolism
Atrial Fibrillation
Thrombosis
Embolism
Venous Thrombosis
Thromboembolism
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases