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

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.

NCT Number	NCT07616414
Lead Sponsor	Fu Wai Hospital, Beijing, China Collaborators: Peking University First Hospital, Fuwai Shenzhen Hospital, Beijing Boai Hospital, China Rehabilitation Research Center
Conditions	Non-valvular Atrial Fibrillation (NVAF), Thromboembolism, Cardiac Implantable Electronic Device, Perioperative Bleeding, Hematoma Postoperative
Enrollment	424 participants
Start Date	2026-05-26
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-01