Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)

NCT07616414 | Not Yet Recruiting

• 1 other identifier: 2026-3143
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief 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 (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.

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; Thromboembolism; Perioperative Bleeding; Randomized Controlled Trial; Edoxaban; Rivaroxaban

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinically Significant Pocket Hematoma

  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.

  Within 30 days after CIED implantation

Secondary Outcomes (1)

• Individual components of the primary endpoint and composite outcomes of other major perioperative bleeding events

  7 days and 30 days after surgery

Study Arms (2)

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.

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.

Drug: Standard Anticoagulation Regimen

Interventions

Stepwise Anticoagulation Regimen DRUG

Experimental 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.

Stepwise Anticoagulation Group

Standard Anticoagulation Regimen DRUG

Active 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.

Standard Anticoagulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead
• Peking University First Hospital: collaborator
• Fuwai Shenzhen Hospital: collaborator
• Beijing Boai Hospital, China Rehabilitation Research Center: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaofei Li, Dr.

CONTACT

(+86)17801013995; lixiaofei0103@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 1, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)