HemorrhageADIOSNCT02935751
Apixaban Discontinuation Prior to Major Surgery
An observational study of Hemorrhage and Thromboembolism, run by Thomas Jefferson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemorrhage, Thromboembolism
- What is being tested?
- Lab tests for plasma levels of apixaban and anti-10a factor
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 130 patients who are currently receiving treatment with apixaban for non-valvular atrial fibrillation and scheduled for an elective surgical procedure.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Hemorrhage, Thromboembolism
- Being tested
- Lab tests for plasma levels of apixaban and anti-10a factor
- Medical subject headings
- Hemorrhage, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab tests for plasma levels of apixaban and anti-10a factorOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Prior to elective surgery
Secondary outcomes (2)
Anti-10a apixaban plasma concentration
Assess changes in anti-Xa apixaban levels following apixaban discontinuation but prior to the procedure
Measured: Prior to elective surgery
30 day outcomes assessment
Incidence of major events within 30 days including bleeding events, arterial thromboembolic events, and deaths caused by bleeding or thrombosis.
Measured: Up to 30 days post- procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Geno J. Merli, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935751
- Sponsor's protocol ID
- 16G.421
- Acronym
- ADIOS
- Status last verified
- Sep 2018
- First submitted
- 14 Oct 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 34809507
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Discontinuation Prior to Major Surgery
- ClinicalTrials.gov ID
- NCT02935751
- Acronym / sponsor ID
- ADIOS / 16G.421
- Conditions
- Hemorrhage, Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130 patients who are currently receiving treatment with apixaban for non-valvular atrial fibrillation and scheduled for an elective surgical procedure.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab tests for plasma levels of apixaban and anti-10a factorAll 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. | Other | – |
Primary outcome
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
2 secondary outcomes
Anti-10a apixaban plasma concentration
Time frame: Prior to elective surgery
30 day outcomes assessment
Time frame: Up to 30 days post- procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Derived from this study: PubMed 34809507Merli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geno J. Merli, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Thromboembolism, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apixaban plasma concentration (time frame: Prior to elective surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.