Stable Angina PectorisPhase 4D-ONENCT07592507
1 or 6 Months of Dual Antiplatelet Therapy After Drug-coated Balloon Angioplasty for De-novo Small Coronary Artery Disease
A Phase 4 study testing 1-Month DAPT followed by SAPT and 6-Month DAPT followed by SAPT in people with Stable Angina Pectoris and Coronary Artery Disease, run by Daejeon St. Mary's hospital.
Trial summary
1. Objective Objective: > The purpose of this study is to evaluate whether a short-term (1-month) dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) is non-inferior to the standard 6-month DAPT in patients undergoing Drug-Coated Balloon (DCB) angioplasty for de novo small coronary artery… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stable Angina Pectoris, Coronary Artery Disease
- What is being tested?
- 1-Month DAPT followed by SAPT and 6-Month DAPT followed by SAPT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,484 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Feb 2032
- Phase
- Phase 4
- 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
- 1)Adults aged 19 years or older 2)Subjects who have undergone drug-coated balloon (DCB) angioplasty 3) Subjects with stable angina, asymptomatic ischemia, and angiographically confirmed coronary lesions 4)Patients who have not undergone coronary intervention and whose coronary angiography demonstrates a reference vessel diameter between 2.0 mm and 3.0 mm, meeting all of the following conditions: No severe dissection corresponding to National Heart, Lung, and Blood Institute (NHLBI) grade C to F No reduction in coronary blood flow defined as TIMI flow grade < 2 No residual stenosis ≥ 30% 5)Patients newly diagnosed with small-vessel coronary artery disease among those maintained on single antiplatelet therapy (SAPT) for at least 6 months after undergoing: de novo percutaneous coronary intervention (de novo PCI),in-stent restenosis PCI (ISR PCI), or percutaneous transluminal coronary angioplasty (PTCA) 6)Subjects who voluntarily agree to participate in this clinical study and provide written informed consent
Who cannot join
- 1) Patients diagnosed with Acute Coronary Syndrome (ACS), including STEMI, NSTEMI, or Unstable Angina.
- 2) Patients undergoing concomitant Percutaneous Coronary Intervention (PCI) during the Drug-Coated Balloon (DCB) procedure.
- 3) Patients undergoing PCI for In-Stent Restenosis (ISR). 4) Patients with a diagnosis of active bleeding or coagulation disorder within 2 months prior to obtaining informed consent.
- 5) Patients who underwent surgery with moderate-to-high risk within 6 weeks prior to obtaining informed consent.
- 6) Patients with a history of intracerebral hemorrhage (ICH). 7) Patients with Hemoglobin < 10 g/dL or Platelet count < 100 x 10³/mm³. 8) Patients unable to discontinue oral anticoagulation therapy (OAC). 9) Patients on long-term treatment with NSAIDs or COX-2 inhibitors (excluding aspirin).
- 10) Patients with a life expectancy of less than 1 year due to malignancy or other comorbidities.
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- 11) Patients with moderate-to-severe hepatic impairment. 12) Patients at risk of symptomatic bradycardia (e.g., 2nd-degree Mobitz Type II block or 3rd-degree AV block).
- 13) Patients with dyspnea, such as those with Chronic Obstructive Pulmonary Disease (COPD).
- 14) Patients with intolerance or hypersensitivity to the investigational medicinal products.
- 15) Patients who participated in other clinical trials within 3 months prior to informed consent (excluding non-interventional observational studies).
- 16) Women who are pregnant or breastfeeding. 17) Patients with End-Stage Renal Disease (ESRD) on hemodialysis or peritoneal dialysis, or those who have undergone a kidney transplant.
- 18) Patients with rare hereditary metabolic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- 19) Any patient deemed unsuitable for participation in the clinical trial at the investigator's discretion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 1 or 6 Months of Dual Antiplatelet Therapy After Drug-Coated Balloon Angioplasty for De Novo Small Coronary Artery Disease: An Open-label, Randomized, Non-inferiority Trial
- Objective Objective: > The purpose of this study is to evaluate whether a short-term (1-month) dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) is non-inferior to the standard 6-month DAPT in patients undergoing Drug-Coated Balloon (DCB) angioplasty for de novo small coronary artery disease. Methods: > This is an open-label, randomized, non-inferiority trial. Patients will be assigned to either 1 month or 6 months of DAPT after successful DCB treatment. The study will compare the incidence of Net Adverse Clinical Events (NACE)-a composite of cardiovascular death, myocardial infarction, target vessel revascularization, and major bleeding-between the two groups from 1 to 12 months post-procedure.
- Background Following percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) is essential to prevent stent thrombosis and ischemic events. While short-duration DAPT (e.g., 4 weeks) has shown benefits in patients at high bleeding risk, evidence regarding the optimal DAPT duration specifically after Drug-Coated Balloon (DCB) angioplasty for small vessel disease remains insufficient. This study aims to fill this clinical gap by comparing 1-month versus 6-month DAPT strategies.
Primary Objective To demonstrate the non-inferiority of 1-month DAPT (followed by SAPT up to 12 months) compared to 6-month DAPT in terms of Net Adverse Clinical Events (NACE) occurring between 1 and 12 months post-randomization.
Secondary Objectives To evaluate ischemic safety (CV death, MI, TLR). To assess bleeding safety (BARC type 2, 3, or 5). To analyze individual components of the primary composite endpoint, including all-cause death and stent thrombosis.
- Conditions
- Stable Angina Pectoris, Coronary Artery Disease
- Being tested
- 1-Month DAPT followed by SAPT, 6-Month DAPT followed by SAPT
- Keywords
- DAPT, aspirin, clopidogrel, drug coated balloon, DCB, dual antiplatelet therapy, small vessel disease
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Month DAPT followed by SAPTDrug
Aspirin 100 mg and Clopidogrel 75 mg daily for 1 month, followed by single antiplatelet therapy (Aspirin 100 mg or Clopidogrel 75 mg) up to 12 months.
6-Month DAPT followed by SAPTDrug
Aspirin 100 mg and Clopidogrel 75 mg daily for 6 months, followed by single antiplatelet therapy (Aspirin 100 mg or Clopidogrel 75 mg) up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| DAPT(aspirin and clopidogrel 1month) | Experimental | Experimental Group (1-Month DAPT: Aspirin + Clopidogrel)
Initial Phase (1 Month): Aspirin 100 mg and Clopidogrel 75 mg administered orally once daily. Receives: Drug: 1-Month DAPT followed by SAPT; Drug: 6-Month DAPT followed by SAPT |
| DAPT(aspirin and clopidogrel 6month) | Active comparator | Control Group (6-Month DAPT: Aspirin + Clopidogrel)
Initial Phase (6 Months): Aspirin 100 mg and Clopidogrel 75 mg administered orally once daily. Receives: Drug: 1-Month DAPT followed by SAPT; Drug: 6-Month DAPT followed by SAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Validation Variables
Cumulative incidence of NACE, defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), target vessel revascularization, and bleeding (BARC type 3 or 5), assessed from the time of first dose of study drug through 12 months.
Measured: Up to 12 months
Secondary outcomes (1)
Secondary Validation Variables:
[Outcome Measure 1] Title: Composite of CV Death, Non-fatal MI, and Target Lesion Revascularization (TLR)
Time Frame: 1, 3, 6, and 12 months
Description: Cumulative incidence of the composite endpoint (cardiovascular death, non-fatal myocardial infarction, and target lesion revascularization).
[Outcome Measure 2] Title: Composite of BARC Bleeding Type 2, 3, or 5
Time Frame: 1, 3, 6, and 12 months
Description: Incidence of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria.
[Outcome Measure 3] Title: Landmark Analysis of NACE between 1 and 12 Months
Time Frame: From 1 month up to 12 months after the index PCI
Description: Composite of CV death, MI, TLR, and BARC bleeding type 3 or 5, assessed specifically for the interval between 1 month and 12 months post-index PCI.
[Outcome Measure 4] Title: Individual Components of Clinical Endpoints
Time Frame: 1, 3, 6, and 12 months
Description: Incidence of each individual component: all-cause death,
Measured: 1,3,6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionFeb 2032 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization performs a stratified block randomization method. An independent control expert from this clinical study generates a random assignment number using Microsoft Windows and gives a random assignment number using an interactive web-based response system, an Internet-based clinical research group assignment management system, to prevent the subjectivity of the researchers from intervening.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daejeon St. Mary's hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Dae-Won, Daejeon St. Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592507
- Sponsor's protocol ID
- DC25MIDI0053
- Acronym
- D-ONE
- Status last verified
- May 2026
- First submitted
- 24 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect the privacy of study participants and to comply with the hospital's Institutional Review Board (IRB) policies and local data protection regulations
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 or 6 Months of Dual Antiplatelet Therapy After Drug-Coated Balloon Angioplasty for De Novo Small Coronary Artery Disease: An Open-label, Randomized, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07592507
- Acronym / sponsor ID
- D-ONE / DC25MIDI0053
- Conditions
- Stable Angina Pectoris, Coronary Artery Disease
- Keywords
- DAPT, aspirin, clopidogrel, drug coated balloon, DCB, dual antiplatelet therapy, small vessel disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,484 participants (estimated)
- Lead sponsor
- Daejeon St. Mary's hospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 18 May 2026 (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.
- Objective Objective: > The purpose of this study is to evaluate whether a short-term (1-month) dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) is non-inferior to the standard 6-month DAPT in patients undergoing Drug-Coated Balloon (DCB) angioplasty for de novo small coronary artery disease. Methods: > This is an open-label, randomized, non-inferiority trial. Patients will be assigned to either 1 month or 6 months of DAPT after successful DCB treatment. The study will compare the incidence of Net Adverse Clinical Events (NACE)-a composite of cardiovascular death, myocardial infarction, target vessel revascularization, and major bleeding-between the two groups from 1 to 12 months post-procedure.
- Background Following percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) is essential to prevent stent thrombosis and ischemic events. While short-duration DAPT (e.g., 4 weeks) has shown benefits in patients at high bleeding risk, evidence regarding the optimal DAPT duration specifically after Drug-Coated Balloon (DCB) angioplasty for small vessel disease remains insufficient. This study aims to fill this clinical gap by comparing 1-month versus 6-month DAPT strategies.
Primary Objective To demonstrate the non-inferiority of 1-month DAPT (followed by SAPT up to 12 months) compared to 6-month DAPT in terms of Net Adverse Clinical Events (NACE) occurring between 1 and 12 months post-randomization.
Secondary Objectives To evaluate ischemic safety (CV death, MI, TLR). To assess bleeding safety (BARC type 2, 3, or 5). To analyze individual components of the primary composite endpoint, including all-cause death and stent thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization performs a stratified block randomization method. An independent control expert from this clinical study generates a random assignment number using Microsoft Windows and gives a random assignment number using an interactive web-based response system, an Internet-based clinical research group assignment management system, to prevent the subjectivity of the researchers from intervening.
| Arm | Type | Receives |
|---|---|---|
| DAPT(aspirin and clopidogrel 1month) | Experimental | Drug: 1-Month DAPT followed by SAPT, Drug: 6-Month DAPT followed by SAPTExperimental Group (1-Month DAPT: Aspirin + Clopidogrel) Initial Phase (1 Month): Aspirin 100 mg and Clopidogrel 75 mg administered orally once daily. |
| DAPT(aspirin and clopidogrel 6month) | Active comparator | Drug: 1-Month DAPT followed by SAPT, Drug: 6-Month DAPT followed by SAPTControl Group (6-Month DAPT: Aspirin + Clopidogrel) Initial Phase (6 Months): Aspirin 100 mg and Clopidogrel 75 mg administered orally once daily. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1)Adults aged 19 years or older 2)Subjects who have undergone drug-coated balloon (DCB) angioplasty 3) Subjects with stable angina, asymptomatic ischemia, and angiographically confirmed coronary lesions 4)Patients who have not undergone coronary intervention and whose coronary angiography demonstrates a reference vessel diameter between 2.0 mm and 3.0 mm, meeting all of the following conditions: No severe dissection corresponding to National Heart, Lung, and Blood Institute (NHLBI) grade C to F No reduction in coronary blood flow defined as TIMI flow grade < 2 No residual stenosis ≥ 30% 5)Patients newly diagnosed with small-vessel coronary artery disease among those maintained on single antiplatelet therapy (SAPT) for at least 6 months after undergoing: de novo percutaneous coronary intervention (de novo PCI),in-stent restenosis PCI (ISR PCI), or percutaneous transluminal coronary angioplasty (PTCA) 6)Subjects who voluntarily agree to participate in this clinical study and provide written informed consent
Key exclusion criteria (13 listed)
- 1) Patients diagnosed with Acute Coronary Syndrome (ACS), including STEMI, NSTEMI, or Unstable Angina.
- 2) Patients undergoing concomitant Percutaneous Coronary Intervention (PCI) during the Drug-Coated Balloon (DCB) procedure.
- 3) Patients undergoing PCI for In-Stent Restenosis (ISR). 4) Patients with a diagnosis of active bleeding or coagulation disorder within 2 months prior to obtaining informed consent.
- 5) Patients who underwent surgery with moderate-to-high risk within 6 weeks prior to obtaining informed consent.
- 6) Patients with a history of intracerebral hemorrhage (ICH). 7) Patients with Hemoglobin < 10 g/dL or Platelet count < 100 x 10³/mm³. 8) Patients unable to discontinue oral anticoagulation therapy (OAC). 9) Patients on long-term treatment with NSAIDs or COX-2 inhibitors (excluding aspirin).
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 |
|---|---|---|
| 1-Month DAPT followed by SAPTAspirin 100 mg and Clopidogrel 75 mg daily for 1 month, followed by single antiplatelet therapy (Aspirin 100 mg or Clopidogrel 75 mg) up to 12 months. | Drug | DAPT(aspirin and clopidogrel 1month), DAPT(aspirin and clopidogrel 6month) |
| 6-Month DAPT followed by SAPTAspirin 100 mg and Clopidogrel 75 mg daily for 6 months, followed by single antiplatelet therapy (Aspirin 100 mg or Clopidogrel 75 mg) up to 12 months. | Drug | DAPT(aspirin and clopidogrel 1month), DAPT(aspirin and clopidogrel 6month) |
Primary outcome
Primary Validation Variables
Time frame: Up to 12 months
Cumulative incidence of NACE, defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), target vessel revascularization, and bleeding (BARC type 3 or 5), assessed from the time of first dose of study drug through 12 months.
1 secondary outcome
Secondary Validation Variables:
Time frame: 1,3,6 and 12 month
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 18 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect the privacy of study participants and to comply with the hospital's Institutional Review Board (IRB) policies and local data protection regulations
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1-Month DAPT followed by SAPT and 6-Month DAPT followed by SAPT in people with Stable Angina Pectoris and Coronary Artery Disease, run by Daejeon St. Mary's hospital.
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 1 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 대원 DW KIM (+82-42-220-9943, mirinesilver@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Validation Variables (time frame: Up to 12 months). 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 18 May 2026.