RecruitingNot ApplicableNCT05305482

DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial

Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial


Sponsor

Yonsei University

Enrollment

3,520 participants

Start Date

Aug 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.


Eligibility

Min Age: 19 Years

Inclusion Criteria3

  • Age ≥19 years
  • All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
  • Provision of informed consent

Exclusion Criteria3

  • Current or potential pregnancy
  • Need of oral anticoagulation therapy
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

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Interventions

DEVICEDrug-coated stent

The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.

DEVICEDrug-eluting stent

The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.


Locations(1)

Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

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NCT05305482


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