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

Primary Purpose

Acute Coronary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drug-coated stent
Drug-eluting stent
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Drug-eluting stent, Dual-antiplatelet therapy, Ticagrelor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DCS group

    DES group

    Arm Description

    Drug-coated stent group

    Drug-eluting stent group

    Outcomes

    Primary Outcome Measures

    Patient-Oriented Composite Endpoint (POCE)
    The composite of all-cause death, MI, or any revascularization

    Secondary Outcome Measures

    Device-Oriented Composite Endpoint (DOCE)
    The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR)
    All-cause death
    All death including cardiovascular death
    Cardiovascular death
    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
    Myocardial infarction
    A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document
    Stroke
    Loss of neurologic function caused by an ischemic or hemorrhagic event
    Stent thrombosis (definite or probable)
    By the Academic Research Consortium-2 Consensus Document
    Any revascularization
    All revascularizations including target-vessel revascularization and and non-target-vessel revascularization
    Target-vessel revascularization
    Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion
    Non-target vessel revascularization
    Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel
    Target-lesion revascularization
    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
    BARC type 2-5 bleeding
    According to a consensus report from the Bleeding Academic Research Consortium
    BARC type 3-5 bleeding
    According to a consensus report from the Bleeding Academic Research Consortium

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    April 7, 2022
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05305482
    Brief Title
    DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial
    Acronym
    ONE-PASS
    Official Title
    Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    May 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome
    Keywords
    Acute coronary syndrome, Drug-eluting stent, Dual-antiplatelet therapy, Ticagrelor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    3520 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DCS group
    Arm Type
    Experimental
    Arm Description
    Drug-coated stent group
    Arm Title
    DES group
    Arm Type
    Active Comparator
    Arm Description
    Drug-eluting stent group
    Intervention Type
    Device
    Intervention Name(s)
    Drug-coated stent
    Other Intervention Name(s)
    BioFreedom Ultra stent
    Intervention Description
    The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.
    Intervention Type
    Device
    Intervention Name(s)
    Drug-eluting stent
    Other Intervention Name(s)
    Ultimaster stent
    Intervention Description
    The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.
    Primary Outcome Measure Information:
    Title
    Patient-Oriented Composite Endpoint (POCE)
    Description
    The composite of all-cause death, MI, or any revascularization
    Time Frame
    At 1 year after randomization
    Secondary Outcome Measure Information:
    Title
    Device-Oriented Composite Endpoint (DOCE)
    Description
    The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR)
    Time Frame
    At 1 year after randomization
    Title
    All-cause death
    Description
    All death including cardiovascular death
    Time Frame
    At 1 year after randomization
    Title
    Cardiovascular death
    Description
    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
    Time Frame
    At 1 year after randomization
    Title
    Myocardial infarction
    Description
    A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document
    Time Frame
    At 1 year after randomization
    Title
    Stroke
    Description
    Loss of neurologic function caused by an ischemic or hemorrhagic event
    Time Frame
    At 1 year after randomization
    Title
    Stent thrombosis (definite or probable)
    Description
    By the Academic Research Consortium-2 Consensus Document
    Time Frame
    At 1 year after randomization
    Title
    Any revascularization
    Description
    All revascularizations including target-vessel revascularization and and non-target-vessel revascularization
    Time Frame
    At 1 year after randomization
    Title
    Target-vessel revascularization
    Description
    Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion
    Time Frame
    At 1 year after randomization
    Title
    Non-target vessel revascularization
    Description
    Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel
    Time Frame
    At 1 year after randomization
    Title
    Target-lesion revascularization
    Description
    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
    Time Frame
    At 1 year after randomization
    Title
    BARC type 2-5 bleeding
    Description
    According to a consensus report from the Bleeding Academic Research Consortium
    Time Frame
    At 1 year after randomization
    Title
    BARC type 3-5 bleeding
    Description
    According to a consensus report from the Bleeding Academic Research Consortium
    Time Frame
    At 1 year after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Myeong-Ki Hong, MD, PhD
    Phone
    +82-2-2228-8458
    Email
    mkhong61@yuhs.ac
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sung-Jin Hong, MD, PhD
    Phone
    +82-2-2228-8452
    Email
    hongs@yuhs.ac
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Myeong-Ki Hong, MD, PhD
    Organizational Affiliation
    Yonsei University Health System, Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data will be available from the principal investigator on reasonable request.

    Learn more about this trial

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

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