Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF) (STEP-AF)
Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xiaofei Li, Dr.
- 電話番号：(+86)17801013995
- メール：lixiaofei0103@163.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100037
- Fuwai Hospital
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コンタクト：
- Xiaofei Li, Dr.
- 電話番号：(+86)010-88322405
- メール：lixiaofei0103@163.com
-
主任研究者：
- Xiaofei Li, M.D, Ph.D.
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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Experimental Regimen: For participants randomized to the stepwise anticoagulation group:
Standard dose reduction criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy. |
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アクティブコンパレータ：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.
|
Active Comparator Regimen: For participants randomized to the standard anticoagulation group:
Standard dose criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Clinically Significant Pocket Hematoma
時間枠：Within 30 days after CIED implantation
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Clinically significant pocket hematoma is defined as hematoma meeting any of the following criteria:
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Within 30 days after CIED implantation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Individual components of the primary endpoint and composite outcomes of other major perioperative bleeding events
時間枠：7 days and 30 days after surgery
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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]).
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7 days and 30 days after surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026-3143
個々の参加者データ (IPD) の計画
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