Apixaban Dose Reduction in Patients With Elevated Drug Levels

NCT ID: NCT02809469

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-08-31

Brief 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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dose reduction

Eligible patients with apixaban levels persistently above 170ng/mL on two occasions, 2 weeks apart, will undergo apixaban dose reduction.

Group Type: EXPERIMENTAL

apixaban dose reduction

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Eliquis dose reduction

Eligibility Criteria

Inclusion Criteria

• Patients with non-valvular atrial fibrillation (permanent, paroxysmal, or persistent) receiving apixaban with any of the following characteristics: age>85; creatinine clearance <40mL/min; or body weight <50kg.

Exclusion Criteria

• Inability to visit Hamilton General Hospital;
• Inability or unwillingness to provide written informed consent.
• Stroke or thromboembolic event in the past 6 months.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinai C. Bhagirath, MD MSc.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Vinai C. Bhagirath, MD MSc.

Role: CONTACT

bhagiv@mcmaster.ca

905 527 1710 ext. 1

John Eikelboom, MBBS MSc.

Role: CONTACT

eikelbj@mcmaster.ca

905 527 4322 ext. 40323

Other Identifiers

ADREL

Identifier Type: -

Identifier Source: org_study_id