이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 5월 23일 업데이트: Li Xiaofei, Fu Wai Hospital, Beijing, China

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

424

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100037
        • Fuwai Hospital
        • 연락하다:
        • 수석 연구원:
          • Xiaofei Li, M.D, Ph.D.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Aged 18 years or older at the time of screening, and able to provide written informed consent;
  2. Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;
  3. Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;
  4. 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.

Exclusion Criteria:

  1. Presence of active systemic or local infection at the time of screening;
  2. Estimated glomerular filtration rate (eGFR) <30 mL/min, or any other contraindication to NOAC use;
  3. Active bleeding (e.g., gastrointestinal bleeding);
  4. Severe thrombocytopenia, defined as platelet count < 50 × 10⁹/L at screening;
  5. Life expectancy <1 year;
  6. Pregnancy.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Stepwise Anticoagulation Group
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.
의약품: Stepwise Anticoagulation Regimen

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.
활성 비교기: Standard Anticoagulation Group
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.
의약품: Standard Anticoagulation Regimen

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Clinically Significant Pocket Hematoma
기간: 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.
Within 30 days after CIED implantation

2차 결과 측정

결과 측정
측정값 설명
기간
Individual components of the primary endpoint and composite outcomes of other major perioperative bleeding events
기간: 7 days and 30 days after surgery
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]).
7 days and 30 days after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fu Wai Hospital, Beijing, China

협력자

Peking University First Hospital
Fuwai Shenzhen Hospital
Beijing Boai Hospital, China Rehabilitation Research Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 26일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 23일

QC 기준을 충족하는 최초 제출

2026년 5월 23일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 23일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-3143

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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