An observational study in Atrial Fibrillation, Deep Vein Thrombosis and Intracardiac Thrombus, sponsored by Cipherome, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Cipherome, Inc. · Observational
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.
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 200 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Cipherome, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Percent time in therapeutic range during initial 12 weeks of warfarin
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)
Time frame: 12 weeks
Time to reach therapeutic INR
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
Time frame: 12 weeks
INR ≥ 4.0 during first 12 weeks of warfarin therapy
Time greater than the desired INR therapeutic range within the first 12 weeks of warfarin therapy
Time frame: 12 weeks
Ischemic stroke
Development of a clinical diagnosis of an ischemic stroke
Time frame: 12 weeks
Major bleeding event during first 12 weeks of warfarin therapy
Development of a major bleeding event during the first 12 weeks of warfarin therapy, diagnosed by a clinician
Time frame: 12 weeks
Clinically relevant non-major bleeding event during the first 12 weeks of warfarin therapy
Development of a clinically relevant non-major bleeding event during the first 12 weeks of warfarin therapy, diagnosed by a clinician
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Cipherome, Inc.