Atrial FibrillationPERIXaNCT05801068
Perioperative Management of Factor Xa Inhibitors
A study testing Factor Xa Inhibitor in people with Atrial Fibrillation and Anticoagulant-induced Bleeding, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation, Anticoagulant-induced Bleeding
- What is being tested?
- Factor Xa Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Aug 2020to 15 May 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >20 years
- With rivaroxaban, apixaban, or edoxaban
- History of non-valvular atrial fibrillation
- Scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic GI endoscopy)
Who cannot join
- Pregnancy
- With rivaroxaban or edoxaban at afternoon
- Mental disorder
- Contraindication to rivaroxaban, apixaban, edoxaban
- Moderate or severe valvular heart disease, or with prosthetic heart valves
- With antiplatelet drugs
- History of systemic embolism or ischemic stroke within the last 12 months
- scheduled therapeutic endoscopic procedure(s)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National university Hostpital
Seoul, Jongno-gu, 03080
About this study
Official title: Effectiveness and Safety of PERIoperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery: A Prospective, Multicenter, Noninterventional Study (PERIXa Study)
This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings
Read the detailed description
- Study design This is a multicenter, non-randomized, investigator-initiated prospective cohort study. The study will analyze the bleeding risk and incidence of cardiovascular events according to the discontinuation/resumption of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are prescribed factor Xa inhibitors for stroke prevention and have minor bleeding risk.
- Study population Patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients), and are facing a procedure defined as having minor bleeding risk.
- Study protocol For patients with non-valvular atrial fibrillation who are prescribed rivaroxaban, apixaban, or edoxaban for stroke prevention and are at risk of minor bleeding, when they visit the prescribing physician (physician A) for consultation and to obtain a medical opinion regarding the discontinuation/resumption of the medication in relation to an invasive procedure, the physician will explain the protocol for discontinuing/resuming the medication and provide a written explanation to ensure that the patient fully understands it.
In addition, the physician in charge of the procedure (physician B) will be notified that the patient has enrolled in this study and will collect information on 1) the type of surgery or procedure performed, and 2) physician B's opinion on the severity of procedure-related bleeding. Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure.
- Being tested
- Factor Xa Inhibitor
- Keywords
- Atrial fibrillation, Perioperative management, Factor Xa inhibitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factor Xa InhibitorDrug
Also called PERIXA group
Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.
| Study group | Role | What they receive |
|---|---|---|
| Periprocedural management of FXa-inhibitor group | Experimental | Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol. Receives: Drug: Factor Xa Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day major bleeding
30-day major bleeding
Measured: Within 30 days after the operation/procedure
Secondary outcomes (3)
30-day stroke or systemic embolism
30-day stroke or systemic embolism
Measured: Within 30 days after the operation/procedure
30-day death from any cause, stroke or systemic embolism
30-day death from any cause, stroke or systemic embolism
Measured: Within 30 days after the operation/procedure
30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding
30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding
Measured: Within 30 days after the operation/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start4 Aug 2020
- Primary completion15 May 2024
- Study completion15 May 2024
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
- Investigators
- Eue-Keun Choi, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801068
- Sponsor's protocol ID
- PERIXa
- Acronym
- PERIXa
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwon S, Lee SR, Choi EK, Lee KY, Choi J, Ahn HJ, Oh S, Lip GYH. Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study. Vasc Health Risk Manag. 2024 May 17;20:231-244. doi: 10.2147/VHRM.S455530. eCollection 2024.
PubMed 38774425
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of PERIoperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery: A Prospective, Multicenter, Noninterventional Study (PERIXa Study)
- ClinicalTrials.gov ID
- NCT05801068
- Acronym / sponsor ID
- PERIXa / PERIXa
- Keywords
- Atrial fibrillation, Perioperative management, Factor Xa inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 6 Apr 2023 (actual)
- 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.
This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings
Detailed description
- Study design This is a multicenter, non-randomized, investigator-initiated prospective cohort study. The study will analyze the bleeding risk and incidence of cardiovascular events according to the discontinuation/resumption of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are prescribed factor Xa inhibitors for stroke prevention and have minor bleeding risk.
- Study population Patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients), and are facing a procedure defined as having minor bleeding risk.
- Study protocol For patients with non-valvular atrial fibrillation who are prescribed rivaroxaban, apixaban, or edoxaban for stroke prevention and are at risk of minor bleeding, when they visit the prescribing physician (physician A) for consultation and to obtain a medical opinion regarding the discontinuation/resumption of the medication in relation to an invasive procedure, the physician will explain the protocol for discontinuing/resuming the medication and provide a written explanation to ensure that the patient fully understands it.
In addition, the physician in charge of the procedure (physician B) will be notified that the patient has enrolled in this study and will collect information on 1) the type of surgery or procedure performed, and 2) physician B's opinion on the severity of procedure-related bleeding. Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periprocedural management of FXa-inhibitor group | Experimental | Drug: Factor Xa InhibitorHold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >20 years
- With rivaroxaban, apixaban, or edoxaban
- History of non-valvular atrial fibrillation
- Scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic GI endoscopy)
Key exclusion criteria (8 listed)
- Pregnancy
- With rivaroxaban or edoxaban at afternoon
- Mental disorder
- Contraindication to rivaroxaban, apixaban, edoxaban
- Moderate or severe valvular heart disease, or with prosthetic heart valves
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 |
|---|---|---|
| Factor Xa InhibitorAlso: PERIXA groupHold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol. | Drug | Periprocedural management of FXa-inhibitor group |
Primary outcome
30-day major bleeding
Time frame: Within 30 days after the operation/procedure
30-day major bleeding
3 secondary outcomes
30-day stroke or systemic embolism
Time frame: Within 30 days after the operation/procedure
30-day death from any cause, stroke or systemic embolism
Time frame: Within 30 days after the operation/procedure
30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding
Time frame: Within 30 days after the operation/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 21 Aug 2026.
- Derived from this study: PubMed 38774425Kwon S, Lee SR, Choi EK, Lee KY, Choi J, Ahn HJ, Oh S, Lip GYH. Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study. Vasc Health Risk Manag. 2024 May 17;20:231-244. doi: 10.2147/VHRM.S455530. eCollection 2024.
- 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.
Eue-Keun Choi, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Factor Xa Inhibitor in people with Atrial Fibrillation and Anticoagulant-induced Bleeding, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 8 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 21 Aug 2026. 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 South Korea. 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?
30-day major bleeding (time frame: Within 30 days after the operation/procedure). 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 NCT05801068, 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 21 Aug 2026.