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NCT Number: NCT05305482

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location status: Recruiting

Location contact

Chul-Min Ahn

CONTACT

[email protected]

82-2-2228-8532

About this study

This trial is an open-label, randomized, multi-center study. Patients with ACS requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of DCS group or DES group. After the index procedure, DAPT (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. After this, ticagrelor monotherapy will be maintained for 11 months. Clinical events will be evaluated within 12 months after randomization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Drug-coated stent

Device

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

Other names: BioFreedom Ultra stent

Drug-Eluting Stent

Device

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

Other names: Ultimaster stent

Primary outcomes

  1. Patient-Oriented Composite Endpoint (POCE)

    Time frame: At 1 year after randomization

    The composite of all-cause death, MI, or any revascularization

Secondary outcomes

  1. Device-Oriented Composite Endpoint (DOCE)

    Time frame: At 1 year after randomization

    The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR)

  2. All-cause death

    Time frame: At 1 year after randomization

    All death including cardiovascular death

  3. Cardiovascular death

    Time frame: At 1 year after randomization

    Death resulting from cardiovascular causes or undetermined cause of death not attributable to any other category because of the absence of any relevant source documents

  4. Myocardial infarction

    Time frame: At 1 year after randomization

    A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document

  5. Stroke

    Time frame: At 1 year after randomization

    Loss of neurologic function caused by an ischemic or hemorrhagic event

  6. Stent thrombosis (definite or probable)

    Time frame: At 1 year after randomization

    By the Academic Research Consortium-2 Consensus Document

  7. Any revascularization

    Time frame: At 1 year after randomization

    All revascularizations including target-vessel revascularization and and non-target-vessel revascularization

  8. Target-vessel revascularization

    Time frame: At 1 year after randomization

    Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion

  9. Non-target vessel revascularization

    Time frame: At 1 year after randomization

    Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel

  10. Target-lesion revascularization

    Time frame: At 1 year after randomization

    Clinically indicated or ischemia driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion

  11. BARC type 2-5 bleeding

    Time frame: At 1 year after randomization

    According to a consensus report from the Bleeding Academic Research Consortium

  12. BARC type 3-5 bleeding

    Time frame: At 1 year after randomization

    According to a consensus report from the Bleeding Academic Research Consortium

Study contacts

Contact information is provided by the study sponsor or research team.

Chul-Min Ahn

CONTACT

[email protected]

+82-2-2228-8532

Sung-Jin Hong, MD, PhD

CONTACT

[email protected]

+82-2-2228-8452

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Acronym: ONE-PASS

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Mar 31, 2022
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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