Apixaban Dose Reduction in Patients With Elevated Drug Levels
Status:
Unknown status
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial
fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious
and safe for the overall AF population; however, patients older than age 85, with creatinine
clearance <40mL/min, or who weighed <50kg were poorly represented in these trials, yet they
are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and
low body weight are all associated with elevated drug levels, and elevated drug levels are
associated with an increased risk of bleeding. Therefore, clinicians are concerned about the
risk of bleeding and are unsure of how best to treat this patient population. Although other
anticoagulants are available, apixaban is attractive because it has a low rate of bleeding,
low dependence on the kidneys for clearance, and does not require frequent ongoing monitoring
and dose adjustment. This study will include patients taking apixaban who were not
well-represented in phase III trials - those with age >85, creatinine clearance <40mL/min, or
weight <50kg - who are also at increased risk of having elevated drug levels due to these
clinical characteristics. Participants will have apixaban levels measured, and those with
persistently elevated levels will have their dose reduced. Drug levels will be measured again
after dose reduction to determine if the levels are reduced without becoming dangerously low.