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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Northern Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Aged ≥ 18 years old

ACS patients with high bleeding risk (meeting the ARC-HBR criteria)

Moderate-to-high ischemic risk (OPT-CAD score ≥ 90)

Predicted by the investigator to be able to tolerate 12 months of DAPT

Disqualifiers

Patients with known allergy or contraindication to P2Y12 inhibitors, aspirin, or contrast agents

Patients planning to undergo surgical intervention within 12 months

Left Ventricular Ejection Fraction (LVEF) < 35%

Patients with contraindications to PCI

Trial design

Treatments tested in this trial

  • IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy
  • Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)

Treatment groups

468 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shenyang Northern Hospital

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator