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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

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.

Condition or disease Intervention/treatment
Hemorrhage Thromboembolism Other: Lab tests for plasma levels of apixaban and anti-10a factor

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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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
Study Population
130 patients who are currently receiving treatment with apixaban for non-valvular atrial fibrillation and scheduled for an elective surgical procedure.
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.

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Bristol-Myers Squibb
Investigators
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Principal Investigator: Geno J. Merli, MD Thomas Jefferson University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02935751    
Other Study ID Numbers: 16G.421
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
Additional relevant MeSH terms:
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Thromboembolism
Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants