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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date October 14, 2016
First Posted Date October 17, 2016
Last Update Posted Date September 12, 2018
Study Start Date October 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2016)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 14, 2016)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Apixaban Discontinuation Prior to Major Surgery
Official Title Apixaban Discontinuation Prior to Major Surgery
Brief 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 130 patients who are currently receiving treatment with apixaban for non-valvular atrial fibrillation and scheduled for an elective surgical procedure.
Condition
  • 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.
Study Groups/Cohorts Not Provided
Publications * Merli GJ, Kraft WK, Eraso LH, Galanis T, Thomson LJ, Ouma GO, Viscusi E, Gong JZ, Lam E. Apixaban Discontinuation for Invasive Or major Surgical procedures (ADIOS): A prospective cohort study. Vasc Med. 2022 Jun;27(3):269-276. doi: 10.1177/1358863X211047270. Epub 2021 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: October 14, 2016)		 130
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02935751
Other Study ID Numbers 16G.421
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Thomas Jefferson University
Original Responsible Party Same as current
Current Study Sponsor Thomas Jefferson University
Original Study Sponsor Same as current
Collaborators Bristol-Myers Squibb
Investigators
Principal Investigator: Geno J. Merli, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date September 2018