NCT02935751

Apixaban Discontinuation Prior to Major Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The ADIOS study is a prospective, observational study will evaluate one hundred and thirty (130) patients with non-valvular atrial fibrillation who are currently receiving treatment with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require an elective major surgical or invasive procedure will be included in the study. The purpose of the study is to evaluate the efficacy of the recommended pre-procedure washout period of 48 hours.

Detailed description

This study will estimate for what proportion of patients a 48 hour pre-procedure apixaban discontinuation is sufficient to achieve minimal apixaban plasma levels (less than 30 ng/mL) prior to surgery. The investigators hypothesize that this portion will be 80-95%. All patients will have a blood draw at 48 hours prior to procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels. Patients will also receive a follow-up phone call at 30 days to collect information on clinical events.

Conditions

• Hemorrhage
• Thromboembolism

Interventions

Type	Name	Description
OTHER	Lab tests for plasma levels of apixaban and anti-10a factor	All patients will have a blood draw at 48 hours prior to elective surgical procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-07-01
• Completion: 2018-09-01
• First posted: 2016-10-17
• Last updated: 2018-09-12

Locations

1 site across 1 country: United States