Non-valvular Atrial Fibrillation (NVAF)STEP-AFNCT07616414
Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)
A study testing Stepwise Anticoagulation Regimen and Standard Anticoagulation Regimen in people with Non-valvular Atrial Fibrillation (NVAF) and Thromboembolism, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial summary
This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF), Thromboembolism, Cardiac Implantable Electronic Device
- What is being tested?
- Stepwise Anticoagulation Regimen and Standard Anticoagulation Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older at the time of screening, and able to provide written informed consent;
- Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;
- Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;
- Diagnosed with non-valvular atrial fibrillation (and/or atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.
Who cannot join
- Presence of active systemic or local infection at the time of screening;
- Estimated glomerular filtration rate (eGFR) <30 mL/min, or any other contraindication to NOAC use;
- Active bleeding (e.g., gastrointestinal bleeding);
- Severe thrombocytopenia, defined as platelet count < 50 × 10⁹/L at screening;
- Life expectancy <1 year;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiaofei Li, Dr., (+86)010-88322405, lixiaofei0103@163.com
Xiaofei Li, M.D, Ph.D.
About this study
Official title: Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)
This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.
Read the detailed description
This is an investigator-initiated, multi-center, prospective, open-label, randomized controlled clinical trial. The study plans to enroll patients with non-valvular atrial fibrillation and/or atrial flutter admitted for CIED implantation, who are assessed as having moderate to high arterial thromboembolic risk (CHA₂DS₂-VASc score ≥2 points) and have received NOACs for at least 5 days before surgery. CIED procedures include implantation and generator replacement; device types include pacemakers (single-chamber, dual-chamber, and cardiac resynchronization therapy pacemakers), defibrillators (single-chamber, dual-chamber, and cardiac resynchronization therapy defibrillators).
Eligible subjects will be enrolled after screening against the inclusion and exclusion criteria. Enrolled subjects will be randomized 1:1 to the intervention group (stepwise anticoagulation group) and the control group (standard anticoagulation group) using a web-based randomization system.
All enrolled subjects will discontinue anticoagulants 1 day before surgery and resume anticoagulant therapy 24 hours after surgery. All subjects receiving anticoagulant therapy will be applied a single elastic bandage compression after removal of the intraoperative compression bandage on the first postoperative day.
For the stepwise anticoagulation group: reduced-dose anticoagulation will be resumed 24 hours after surgery, and standard-dose anticoagulation will be restored on the 7th postoperative day. For the standard anticoagulation group: standard-dose anticoagulation will be resumed 24 hours after surgery.
Subjects will be followed up daily during hospitalization for monitor of pacemaker pocket bleeding, bleeding at other sites, and systemic embolism events. On the day before discharge, the following indicators will be evaluated: complete blood count (hemoglobin, hematocrit [HCT]), length of hospital stay, and in-hospital pacemaker pocket intervention (e.g., additional compression beyond the standard compression protocol, pocket revision, pocket hematoma evacuation, etc.).
On the 7th postoperative day, subjects will return to the hospital for suture removal, during which the following will be evaluated: CIED pocket bleeding (visual assessment), bleeding at other sites, venous blood hemoglobin, hematocrit, symptomatic systemic embolism events (including symptomatic stroke and other systemic embolism events), venous thromboembolic events, all-cause mortality, CIED-related infection, and EuroQol health index scale.
Endpoint events will be assessed by a trained team of physicians and nurses who are blinded to treatment allocation and not involved in clinical decision-making. The study will follow the intention-to-treat (ITT) principle (follow-up, assessment, and analysis based on randomization results). The superiority of the perioperative stepwise anticoagulation regimen versus the standard anticoagulation regimen for CIED procedures will be evaluated through the primary and secondary endpoints in multiple dimensions, in order to provide high-quality clinical evidence for perioperative anticoagulation decision-making for CIED implantation.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Thromboembolism, Cardiac Implantable Electronic Device, Perioperative Bleeding, Hematoma Postoperative
- Being tested
- Stepwise Anticoagulation Regimen, Standard Anticoagulation Regimen
- Keywords
- Non-valvular atrial fibrillation, Cardiac Implantable Electronic Device, CIED, Perioperative Anticoagulation, Non-Vitamin K Antagonist Oral Anticoagulant, NOAC, Stepwise Anticoagulation, Postoperative hematoma, Thromboembolism, Perioperative Bleeding, Randomized Controlled Trial, Edoxaban, Rivaroxaban
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise Anticoagulation RegimenDrug
Experimental Regimen: For participants randomized to the stepwise anticoagulation group:
- Discontinue edoxaban/rivaroxaban 1 day before CIED surgery (i.e., the last dose is administered on the day before surgery);
- Resume reduced-dose edoxaban/rivaroxaban 24 hours after surgery: (1) For edoxaban: 15mg once daily for patients with standard 30mg dose, 30mg once daily for patients with standard 60mg dose; (2) For rivaroxaban: 10mg once daily for patients with standard 15mg dose, 15mg once daily for patients with standard 20mg dose.
- Continue reduced-dose edoxaban/rivaroxaban until suture removal on postoperative day 7;
- Resume standard-dose edoxaban (30mg/60mg once daily) or rivaroxaban (15mg/20mg once daily) after suture removal.
Standard dose reduction criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy.
Standard Anticoagulation RegimenDrug
Active Comparator Regimen: For participants randomized to the standard anticoagulation group:
- Discontinue edoxaban/rivaroxaban 1 day before CIED surgery(i.e., the last dose is administered on the day before surgery);
- Resume full standard-dose edoxaban (30mg/60mg once daily) or rivaroxaban (15mg/20mg once daily) 24 hours after surgery;
- Continue standard-dose edoxaban/rivaroxaban throughout the 30-day follow-up period.
Standard dose criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| Stepwise Anticoagulation Group | Experimental | Participants in this arm will receive the stepwise edoxaban/rivaroxaban anticoagulation regimen: reduced-dose edoxaban/rivaroxaban from 24 hours after CIED surgery until postoperative day 7, followed by standard-dose edoxaban/rivaroxaban for the remainder of the 30-day follow-up period. Receives: Drug: Stepwise Anticoagulation Regimen |
| Standard Anticoagulation Group | Active comparator | Participants in this arm will receive the guideline-recommended standard edoxaban/rivaroxaban anticoagulation regimen: full standard-dose edoxaban/rivaroxaban resumed 24 hours after CIED surgery, continued throughout the 30-day follow-up period. Receives: Drug: Standard Anticoagulation Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant Pocket Hematoma
Clinically significant pocket hematoma is defined as hematoma meeting any of the following criteria:
- Requiring surgical reintervention;
- Leading to prolonged hospital stay beyond the planned discharge date;
- Necessitating interruption of NOAC therapy.
Measured: Within 30 days after CIED implantation
Secondary outcomes (1)
Individual components of the primary endpoint and composite outcomes of other major perioperative bleeding events
Incidence of each individual component of the primary endpoint (hematoma requiring reoperation, prolonged hospital stay, NOAC interruption), composite outcomes of other major perioperative bleeding events (transient ischemic attack or stroke; deep vein thrombosis; pulmonary embolism; peripheral embolism of the extremities or other major organs) and other secondary outcomes (all-cause death; device-related infections requiring hospitalization; other complications related to device implantation [e.g., lead dislocation, perforation]).
Measured: 7 days and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start26 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Fuwai Shenzhen Hospital, Beijing Boai Hospital, China Rehabilitation Research Center
- Responsible party
- Principal investigator, Li Xiaofei, Fu Wai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616414
- Sponsor's protocol ID
- 2026-3143
- Acronym
- STEP-AF
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)
- ClinicalTrials.gov ID
- NCT07616414
- Acronym / sponsor ID
- STEP-AF / 2026-3143
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Thromboembolism, Cardiac Implantable Electronic Device, Perioperative Bleeding, Hematoma Postoperative
- Keywords
- Non-valvular atrial fibrillation, Cardiac Implantable Electronic Device, CIED, Perioperative Anticoagulation, Non-Vitamin K Antagonist Oral Anticoagulant, NOAC, Stepwise Anticoagulation, Postoperative hematoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Fuwai Shenzhen Hospital, Beijing Boai Hospital, China Rehabilitation Research Center
- Study start
- 26 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jun 2026 (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 is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.
Detailed description
This is an investigator-initiated, multi-center, prospective, open-label, randomized controlled clinical trial. The study plans to enroll patients with non-valvular atrial fibrillation and/or atrial flutter admitted for CIED implantation, who are assessed as having moderate to high arterial thromboembolic risk (CHA₂DS₂-VASc score ≥2 points) and have received NOACs for at least 5 days before surgery. CIED procedures include implantation and generator replacement; device types include pacemakers (single-chamber, dual-chamber, and cardiac resynchronization therapy pacemakers), defibrillators (single-chamber, dual-chamber, and cardiac resynchronization therapy defibrillators).
Eligible subjects will be enrolled after screening against the inclusion and exclusion criteria. Enrolled subjects will be randomized 1:1 to the intervention group (stepwise anticoagulation group) and the control group (standard anticoagulation group) using a web-based randomization system.
All enrolled subjects will discontinue anticoagulants 1 day before surgery and resume anticoagulant therapy 24 hours after surgery. All subjects receiving anticoagulant therapy will be applied a single elastic bandage compression after removal of the intraoperative compression bandage on the first postoperative day.
For the stepwise anticoagulation group: reduced-dose anticoagulation will be resumed 24 hours after surgery, and standard-dose anticoagulation will be restored on the 7th postoperative day. For the standard anticoagulation group: standard-dose anticoagulation will be resumed 24 hours after surgery.
Subjects will be followed up daily during hospitalization for monitor of pacemaker pocket bleeding, bleeding at other sites, and systemic embolism events. On the day before discharge, the following indicators will be evaluated: complete blood count (hemoglobin, hematocrit [HCT]), length of hospital stay, and in-hospital pacemaker pocket intervention (e.g., additional compression beyond the standard compression protocol, pocket revision, pocket hematoma evacuation, etc.).
On the 7th postoperative day, subjects will return to the hospital for suture removal, during which the following will be evaluated: CIED pocket bleeding (visual assessment), bleeding at other sites, venous blood hemoglobin, hematocrit, symptomatic systemic embolism events (including symptomatic stroke and other systemic embolism events), venous thromboembolic events, all-cause mortality, CIED-related infection, and EuroQol health index scale.
Endpoint events will be assessed by a trained team of physicians and nurses who are blinded to treatment allocation and not involved in clinical decision-making. The study will follow the intention-to-treat (ITT) principle (follow-up, assessment, and analysis based on randomization results). The superiority of the perioperative stepwise anticoagulation regimen versus the standard anticoagulation regimen for CIED procedures will be evaluated through the primary and secondary endpoints in multiple dimensions, in order to provide high-quality clinical evidence for perioperative anticoagulation decision-making for CIED implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepwise Anticoagulation Group | Experimental | Drug: Stepwise Anticoagulation RegimenParticipants in this arm will receive the stepwise edoxaban/rivaroxaban anticoagulation regimen: reduced-dose edoxaban/rivaroxaban from 24 hours after CIED surgery until postoperative day 7, followed by standard-dose edoxaban/rivaroxaban for the remainder of the 30-day follow-up period. |
| Standard Anticoagulation Group | Active comparator | Drug: Standard Anticoagulation RegimenParticipants in this arm will receive the guideline-recommended standard edoxaban/rivaroxaban anticoagulation regimen: full standard-dose edoxaban/rivaroxaban resumed 24 hours after CIED surgery, continued throughout the 30-day follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older at the time of screening, and able to provide written informed consent;
- Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;
- Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;
- Diagnosed with non-valvular atrial fibrillation (and/or atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.
Key exclusion criteria (6 listed)
- Presence of active systemic or local infection at the time of screening;
- Estimated glomerular filtration rate (eGFR) <30 mL/min, or any other contraindication to NOAC use;
- Active bleeding (e.g., gastrointestinal bleeding);
- Severe thrombocytopenia, defined as platelet count < 50 × 10⁹/L at screening;
- Life expectancy <1 year;
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 |
|---|---|---|
| Stepwise Anticoagulation RegimenExperimental Regimen: For participants randomized to the stepwise anticoagulation group: 1. Discontinue edoxaban/rivaroxaban 1 day before CIED surgery (i.e., the last dose is administered on the day before surgery); 2. Resume reduced-dose edoxaban/rivaroxaban 24 hours after surgery: (1) For edoxaban: 15mg once daily for patients with standard 30mg dose, 30mg once daily for patients with standard 60mg dose; (2) For rivaroxaban: 10mg once daily for patients with standard 15mg dose, 15mg once daily for patients with standard 20mg dose. 3. Continue reduced-dose edoxaban/rivaroxaban until suture removal on postoperative day 7; 4. Resume standard-dose edoxaban (30mg/60mg once daily) or rivaroxaban (15mg/20mg once daily) after suture removal. Standard dose reduction criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy. | Drug | Stepwise Anticoagulation Group |
| Standard Anticoagulation RegimenActive Comparator Regimen: For participants randomized to the standard anticoagulation group: 1. Discontinue edoxaban/rivaroxaban 1 day before CIED surgery(i.e., the last dose is administered on the day before surgery); 2. Resume full standard-dose edoxaban (30mg/60mg once daily) or rivaroxaban (15mg/20mg once daily) 24 hours after surgery; 3. Continue standard-dose edoxaban/rivaroxaban throughout the 30-day follow-up period. Standard dose criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy. | Drug | Standard Anticoagulation Group |
Primary outcome
Incidence of Clinically Significant Pocket Hematoma
Time frame: Within 30 days after CIED implantation
Clinically significant pocket hematoma is defined as hematoma meeting any of the following criteria: 1. Requiring surgical reintervention; 2. Leading to prolonged hospital stay beyond the planned discharge date; 3. Necessitating interruption of NOAC therapy.
1 secondary outcome
Individual components of the primary endpoint and composite outcomes of other major perioperative bleeding events
Time frame: 7 days and 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise Anticoagulation Regimen and Standard Anticoagulation Regimen in people with Non-valvular Atrial Fibrillation (NVAF) and Thromboembolism, run by Fu Wai Hospital, Beijing, China at 1 site in China.
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 6 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: opening soon, as of the sponsor's last update on 1 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofei Li, Dr. ((+86)17801013995, lixiaofei0103@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant Pocket Hematoma (time frame: Within 30 days after CIED implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.