Apixaban Discontinuation Prior to Major Surgery

Hemorrhage Clinical Trial

— ADIOS  

Official title:

Apixaban Discontinuation Prior to Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935751
• Other study ID #: 16G.421
• Status: Completed
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• At least 18 years of age

• On long term anticoagulation with apixaban for treatment of non-valvular atrial fibrillation or venous thromboembolism

• Undergoing elective major surgery or invasive procedure

Exclusion Criteria:

• Inability to obtain informed consent for the blood sample draws

• Any condition precluding collection of follow-up information

• Participation in another clinical trial

• Apixaban Package Insert Recommendations and Cautions

• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.

• Women must not be breastfeeding

• WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of study drug apixaban (approximately 3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post- treatment completion.

• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of the study drug (approximately 3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.

• Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However WOCBP must still undergo pregnancy testing as described.

• The safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves. Therefore, use is not recommended in these patients.

Related Conditions & MeSH terms

• Hemorrhage
• Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apixaban plasma concentration	Determine whether the recommended 48 hour pre-procedure discontinuation period is sufficient to achieve minimal apixaban plasma concentration of < 30 ng/ml prior to surgery	Prior to elective surgery
Secondary	Anti-10a apixaban plasma concentration	Assess changes in anti-Xa apixaban levels following apixaban discontinuation but prior to the procedure	Prior to elective surgery
Secondary	30 day outcomes assessment	Incidence of major events within 30 days including bleeding events, arterial thromboembolic events, and deaths caused by bleeding or thrombosis.	Up to 30 days post- procedure