Apixaban Discontinuation Prior to Major Surgery (ADIOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02935751|
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : September 12, 2018
|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.
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|