Apixaban Discontinuation Prior to Major Surgery (ADIOS)
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|ClinicalTrials.gov Identifier: NCT02935751|
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : September 12, 2018
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|Condition or disease||Intervention/treatment|
|Hemorrhage Thromboembolism||Other: Lab tests for plasma levels of apixaban and anti-10a factor|
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.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Apixaban Discontinuation Prior to Major Surgery|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||September 2018|
- 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.
- Apixaban plasma concentration [ Time Frame: Prior to elective surgery ]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
- Anti-10a apixaban plasma concentration [ Time Frame: Prior to elective surgery ]Assess changes in anti-Xa apixaban levels following apixaban discontinuation but prior to the procedure
- 30 day outcomes assessment [ Time Frame: Up to 30 days post- procedure ]Incidence of major events within 30 days including bleeding events, arterial thromboembolic events, and deaths caused by bleeding or thrombosis.
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935751
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Geno J. Merli, MD||Thomas Jefferson University|
|Responsible Party:||Thomas Jefferson University|
|Other Study ID Numbers:||
|First Posted:||October 17, 2016 Key Record Dates|
|Last Update Posted:||September 12, 2018|
|Last Verified:||September 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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