[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637597":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":60,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Fu Wai Hospital, Beijing, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stepwise Anticoagulation Group","EXPERIMENTAL","Participants in this arm will receive the stepwise edoxaban\u002Frivaroxaban anticoagulation regimen: reduced-dose edoxaban\u002Frivaroxaban from 24 hours after CIED surgery until postoperative day 7, followed by standard-dose edoxaban\u002Frivaroxaban for the remainder of the 30-day follow-up period.",[13],"Drug: Stepwise Anticoagulation Regimen",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Anticoagulation Group","ACTIVE_COMPARATOR","Participants in this arm will receive the guideline-recommended standard edoxaban\u002Frivaroxaban anticoagulation regimen: full standard-dose edoxaban\u002Frivaroxaban resumed 24 hours after CIED surgery, continued throughout the 30-day follow-up period.",[19],"Drug: Standard Anticoagulation Regimen",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Stepwise Anticoagulation Regimen","Experimental Regimen: For participants randomized to the stepwise anticoagulation group:\n\n1. Discontinue edoxaban\u002Frivaroxaban 1 day before CIED surgery (i.e., the last dose is administered on the day before surgery);\n2. Resume reduced-dose edoxaban\u002Frivaroxaban 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.\n3. Continue reduced-dose edoxaban\u002Frivaroxaban until suture removal on postoperative day 7;\n4. Resume standard-dose edoxaban (30mg\u002F60mg once daily) or rivaroxaban (15mg\u002F20mg once daily) after suture removal.\n\nStandard dose reduction criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Anticoagulation Regimen","Active Comparator Regimen: For participants randomized to the standard anticoagulation group:\n\n1. Discontinue edoxaban\u002Frivaroxaban 1 day before CIED surgery(i.e., the last dose is administered on the day before surgery);\n2. Resume full standard-dose edoxaban (30mg\u002F60mg once daily) or rivaroxaban (15mg\u002F20mg once daily) 24 hours after surgery;\n3. Continue standard-dose edoxaban\u002Frivaroxaban throughout the 30-day follow-up period.\n\nStandard dose criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiaofei Li, Dr.","CONTACT","(+86)17801013995","lixiaofei0103@163.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fuwai Hospital","Beijing","Beijing Municipality","100037","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52,54],{"name":33,"role":34,"phone":53,"phoneExt":26,"email":36},"(+86)010-88322405",{"name":55,"role":56,"phone":26,"phoneExt":26,"email":26},"Xiaofei Li, M.D, Ph.D.","PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Li Xiaofei","Dr.",[61,63,66],{"name":62,"class":6},"Peking University First Hospital",{"name":64,"class":65},"Fuwai Shenzhen Hospital","UNKNOWN",{"name":67,"class":65},"Beijing Boai Hospital, China Rehabilitation Research Center","100637597","stepwise-vs-standard-anticoagulation-for-af-patients-undergoing-cied-implantation-step-af-100637597",false,"NCT07616414","Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)","Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)","STEP-AF","Inclusion Criteria:\n\n1. Aged 18 years or older at the time of screening, and able to provide written informed consent;\n2. Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;\n3. Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;\n4. Diagnosed with non-valvular atrial fibrillation (and\u002For atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.\n\nExclusion Criteria:\n\n1. Presence of active systemic or local infection at the time of screening;\n2. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin, or any other contraindication to NOAC use;\n3. Active bleeding (e.g., gastrointestinal bleeding);\n4. Severe thrombocytopenia, defined as platelet count \\\u003C 50 × 10⁹\u002FL at screening;\n5. Life expectancy \\\u003C1 year;\n6. Pregnancy.","ALL","18 Years",{"count":79,"type":80},424,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.",[86,87,88,89,90],"Non-valvular Atrial Fibrillation (NVAF)","Thromboembolism","Cardiac Implantable Electronic Device","Perioperative Bleeding","Hematoma Postoperative",[92,88,93,94,95,96,97,98,87,89,99,100,101],"Non-valvular atrial fibrillation","CIED","Perioperative Anticoagulation","Non-Vitamin K Antagonist Oral Anticoagulant","NOAC","Stepwise Anticoagulation","Postoperative hematoma","Randomized Controlled Trial","Edoxaban","Rivaroxaban","NOT_YET_RECRUITING","2026-05-23",{"date":105,"type":106},"2026-06-01","ACTUAL",{"date":108,"type":80},"2026-05-26",{"date":110,"type":80},"2026-12-31",{"name":5,"class":6},1]