CompletedNot Applicable

Association Between Genetic Variant Scores and Warfarin Effect

United States200 participantsStarted 2019-02-11

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

Who can participate

Age range18 Years – 99 Years

SexALL

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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.

What they're measuring

Percent time in therapeutic range during initial 12 weeks of warfarin

Timeframe: 12 weeks

Trial details

NCT IDNCT03894878

SponsorCipherome, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Atrial Fibrillation trials