Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Christopher Granger, MD
With
Bristol-Myers Squibb
This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females, age at least 18 years, or the local age of consent, whichever is greater.
Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).
CHA2DS2-VASc score of ≥ 2.
End-stage renal disease treated with hemodialysis for ≥ 3 months.
Considered by the treating physician(s) to be candidate for oral anticoagulation.
If of childbearing potential, be willing to avoid pregnancy during the study.
You may not be if
Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin \< 8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
Moderate or severe mitral stenosis
Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
Need for aspirin at a dose \> 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
Life expectancy \< 3 months
Anticipated kidney transplant within the next 3 months
Prisoners or others who are involuntarily incarcerated or detained
Pregnant, breastfeeding, or considering pregnancy.
Participation in a clinical trial of an experimental treatment within the past 30 days
Clareo Health | Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
