Acute Coronary SyndromeONE-PASSNCT05305482
DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial
A study testing Drug-coated stent and Drug-eluting stent in people with Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Drug-coated stent and Drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,520 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2022to 14 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
Chul-Min Ahn, 82-2-2228-8532, drcello@yuhs.ac
About this study
Official title: Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Drug-coated stent, Drug-eluting stent
- Keywords
- Acute coronary syndrome, Drug-eluting stent, Dual-antiplatelet therapy, Ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated stentDevice
Also called BioFreedom Ultra stent
The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.
Drug-eluting stentDevice
Also called Ultimaster stent
The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.
| Study group | Role | What they receive |
|---|---|---|
| DCS group | Experimental | Drug-coated stent group Receives: Device: Drug-coated stent |
| DES group | Active comparator | Drug-eluting stent group Receives: Device: Drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Oriented Composite Endpoint (POCE)
The composite of all-cause death, MI, or any revascularization
Measured: At 1 year after randomization
Secondary outcomes (12)
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)
Measured: At 1 year after randomization
All-cause death
All death including cardiovascular death
Measured: At 1 year after randomization
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
Measured: At 1 year after randomization
Myocardial infarction
A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document
Measured: At 1 year after randomization
Stroke
Loss of neurologic function caused by an ischemic or hemorrhagic event
Measured: At 1 year after randomization
Stent thrombosis (definite or probable)
By the Academic Research Consortium-2 Consensus Document
Measured: At 1 year after randomization
Any revascularization
All revascularizations including target-vessel revascularization and and non-target-vessel revascularization
Measured: At 1 year after randomization
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
Measured: At 1 year after randomization
Non-target vessel revascularization
Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel
Measured: At 1 year after randomization
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
Measured: At 1 year after randomization
BARC type 2-5 bleeding
According to a consensus report from the Bleeding Academic Research Consortium
Measured: At 1 year after randomization
BARC type 3-5 bleeding
According to a consensus report from the Bleeding Academic Research Consortium
Measured: At 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start10 Aug 2022
- Primary completion14 Feb 2030 (estimated)
- Study completion14 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Min Ahn, Yonsei University
- Investigators
- Chul-Min Ahn, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305482
- Sponsor's protocol ID
- 1-2021-0089
- Acronym
- ONE-PASS
- Status last verified
- May 2025
- First submitted
- 22 Mar 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
- ClinicalTrials.gov ID
- NCT05305482
- Acronym / sponsor ID
- ONE-PASS / 1-2021-0089
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Drug-eluting stent, Dual-antiplatelet therapy, Ticagrelor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,520 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 14 Feb 2030 (estimated)
- Study completion
- 14 Feb 2030 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCS group | Experimental | Device: Drug-coated stentDrug-coated stent group |
| DES group | Active comparator | Device: Drug-eluting stentDrug-eluting stent group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-coated stentAlso: BioFreedom Ultra stentThe polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group. | Device | DCS group |
| Drug-eluting stentAlso: Ultimaster stentThe Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group. | Device | DES group |
Primary outcome
Patient-Oriented Composite Endpoint (POCE)
Time frame: At 1 year after randomization
The composite of all-cause death, MI, or any revascularization
12 secondary outcomes
Device-Oriented Composite Endpoint (DOCE)
Time frame: At 1 year after randomization
All-cause death
Time frame: At 1 year after randomization
Cardiovascular death
Time frame: At 1 year after randomization
Myocardial infarction
Time frame: At 1 year after randomization
Stroke
Time frame: At 1 year after randomization
Stent thrombosis (definite or probable)
Time frame: At 1 year after randomization
Any revascularization
Time frame: At 1 year after randomization
Target-vessel revascularization
Time frame: At 1 year after randomization
Non-target vessel revascularization
Time frame: At 1 year after randomization
Target-lesion revascularization
Time frame: At 1 year after randomization
BARC type 2-5 bleeding
Time frame: At 1 year after randomization
BARC type 3-5 bleeding
Time frame: At 1 year after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No. The data will be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chul-Min Ahn principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-coated stent and Drug-eluting stent in people with Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chul-Min Ahn (+82-2-2228-8532, drcello@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Oriented Composite Endpoint (POCE) (time frame: At 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.