A Phase 2 interventional study of apixaban dose reduction in Atrial Fibrillation, sponsored by Hamilton Health Sciences Corporation. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2016-06-22.
Sponsored by Hamilton Health Sciences Corporation · Phase 2, Interventional, and Prevention
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 120 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Eligible patients with apixaban levels persistently above 170ng/mL on two occasions, 2 weeks apart, will undergo apixaban dose reduction.
Drug: apixaban dose reduction
Participants taking apixaban 5mg BID will have their dose reduced to 2.5mg BID, and those taking 2.5mg BID will have their dose reduced to 2.5mg once daily (in the morning).
Also known as: Eliquis dose reduction
Proportion of patients who achieve target range
Patients who undergo dose reduction will have their apixaban drug level measured one week later. The proportion who develop levels between 50-170ng/mL after dose reduction will be determined.
Time frame: 1 week after dose reduction
Proportion of patients with persistently elevated levels
Patients meeting inclusion criteria will have apixaban drug levels measured. Those with levels above 170ng/mL will have levels repeated 2 weeks later. The proportion of eligible patients with levels above 170ng/mL on both occasions will be determined.
Time frame: 2 weeks after initial blood work
Proportion of patients who spontaneously develop levels below the median of the observed on-therapy range
Patients meeting inclusion criteria will have apixaban drug levels measured. Those with levels above 170ng/mL will have levels repeated 2 weeks later. The proportion of patients with levels above 170ng/mL on the first measurement who spontaneously develop levels below 122ng/mL on the second measurement will be determined.
Time frame: 2 weeks after initial blood work
Proportion of patients who develop low levels after dose reduction
Patients who undergo dose reduction will have apixaban drug levels measured 7-10 days after dose reduction. The proportion of patients with drug levels below 50ng/mL after dose reduction will be determined.
Time frame: 1 week after dose reduction
Plan to share: No
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This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Hamilton Health Sciences Corporation