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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935751
Other study ID # 16G.421
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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