MedTrace Logo

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

NCT07374718 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome (ACS)
  • High Bleeding Risk(HBR)
  • Coronary Artery Disease (CAD)

Interventions

DEVICE

IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy

Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ polymer-free drug-coated stent, followed by 1-month dual antiplatelet therapy (DAPT: aspirin + P2Y12 inhibitor) and 11-month P2Y12 inhibitor monotherapy for ACS patients with high bleeding and intermediate-to-high ischemic risk.

DEVICE

Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)

Coronary angiography-guided implantation of conventional drug-eluting stent (DES), with 12-month standard DAPT (aspirin + P2Y12 inhibitor) for the same patient population.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Shenyang Northern Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-30
Completion
2029-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374718 on ClinicalTrials.gov