Clinical Trial

Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk

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Summary
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy (DAPT) may reduce ischemic events but increases bleeding complications.This prospective, multicenter, randomized controlled study evaluates the safety and effectiveness of an optimized PCI and antiplatelet therapy strategy in ACS patients with moderate-to-high ischemic risk and high bleeding risk. Eligible patients will be randomized in a 1:1 ratio to either an experimental strategy consisting of intravascular ultrasound-guided implantation of a polymer-free drug-coated stent followed by one month of DAPT and subsequent single antiplatelet therapy, or a control strategy consisting of angiography-guided implantation of contemporary drug-eluting stents followed by standard 12-month DAPT.The primary hypothesis is that the experimental strategy will reduce the incidence of net adverse clinical events, defined as a composite of ischemic and bleeding outcomes, compared with conventional PCI and prolonged DAPT. Participants will be followed for 12 months after the index procedure.
Trial Details
NCT Number NCT07374718
Lead Sponsor Shenyang Northern Hospital
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR), Coronary Artery Disease (CAD)
Enrollment 468 participants
Start Date 2026-03-01
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-29