Coronary Artery Disease (CAD)ADAPT-DCBNCT07879430
1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention
A study testing 1-Month DAPT and 6-Month DAPT in people with Coronary Artery Disease (CAD), run by Ulsan University Hospital.
Trial summary
This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- 1-Month DAPT and 6-Month DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,258 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 31 Oct 2029
- 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
[Inclusion Criteria]
- Age ≥19 years.
- Written informed consent obtained before randomization and before any study-specific procedures. The conditions allowing consent before or after PCI follow the footnote of the Schedule of Assessments.
- Presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS, including unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction), and clinically stable after PCI.
- Has an indication for coronary PCI based on symptoms, objective ischemia, ACS clinical presentation, coronary physiology, or angiographic findings per routine practice.
- All treated lesions were treated with the Pantera Lux DCB only and Successful DCB-only PCI in all treated lesions, with visually estimated residual diameter stenosis ≤30%, TIMI grade 3 flow, and no flow-limiting dissection, persistent ischemia, or unresolved major procedural complications.
- No coronary stent or scaffold was implanted during the index procedure.
- Able and willing to comply with the assigned antiplatelet regimen and scheduled follow-up, and judged by the investigator to be clinically acceptable for both the 1-month and 6-month DAPT strategies using the P2Y12 inhibitor selected by the investigator.
[Exclusion Criteria]
- Unable or unwilling to provide written informed consent.
- Known contraindication, hypersensitivity, or clinically unacceptable intolerance to aspirin, any P2Y12 inhibitor permitted by the protocol, heparin, paclitaxel, DCB excipients, or iodinated contrast media that cannot be adequately controlled.
- Active major bleeding at the time of randomization, or another condition that precludes DAPT.
- Requires, or is expected to require, oral anticoagulation after randomization; or has a separate clinical indication, independent of study assignment, that necessitates DAPT beyond 1 month or makes it impossible to maintain 6-month DAPT, such that one of the two assigned strategies would be inappropriate.
- Cardiogenic shock, persistent hemodynamic instability, or need for mechanical circulatory support at randomization.
- Bailout or planned coronary stent/scaffold implantation during the index procedure.
- Additional PCI (including DCB-only PCI) or CABG planned within the first 6 months after randomization.
- Coronary stent implantation within 6 months before randomization.
- History of definite or probable stent thrombosis.
- In-stent restenosis or stent thrombosis as the study target lesion.
- Prior coronary artery bypass grafting (CABG).
- Life expectancy <1 year due to comorbid conditions.
- Currently participating in another interventional study that may interfere with treatment or endpoint ascertainment.
- Pregnant or breastfeeding, or planning pregnancy during the assigned DAPT period.
- Any other condition in which, in the investigator's judgment, study participation is unsafe or reliable follow-up is unlikely.
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-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention (ADAPT-DCB)
This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). The study will evaluate net adverse clinical events (NACE) at 12 months to assess whether short-term 1-month DAPT is non-inferior to 6-month DAPT. The study is a prospective, randomized, open-label, blinded-endpoint, multicenter trial.
Read the detailed description
This study evaluates whether a short-term 1-month dual antiplatelet therapy (DAPT) strategy is non-inferior to the standard 6-month DAPT strategy in patients who have undergone successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI).
Patients aged 19 years or older presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who achieve successful treatment with drug-coated balloons without any permanent stent or scaffold implantation will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either 1-month DAPT followed by single antiplatelet therapy (SAPT) or standard 6-month DAPT followed by SAPT. The primary endpoint is the time to first net adverse clinical events (NACE) from randomization through 12 months, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
Secondary outcomes include individual components of NACE, target lesion failure (TLF), total bleeding events according to BARC criteria, and clinical outcomes evaluated at a pre-specified 30-day landmark analysis. Clinical events will be adjudicated by an independent Clinical Events Committee.
This is a prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE), parallel-group, non-inferiority study. If clinically indicated, antiplatelet therapy may be modified or adjusted according to the investigator's clinical judgment with proper documentation.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- 1-Month DAPT, 6-Month DAPT
- Keywords
- Dual Antiplatelet Therapy, Drug-Coated Balloon, Percutaneous Coronary Intervention, Coronary Artery Disease, Short-Term DAPT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Month DAPTDrug
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month (30 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 25 and 35, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.
6-Month DAPTDrug
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months (180 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 166 and 194, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1-Month DAPT Group | Experimental | Patients receiving successful drug-coated balloon-only PCI will undergo dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month post-procedure, followed by single antiplatelet therapy (SAPT). Receives: Drug: 1-Month DAPT |
| 6-Month DAPT Group | Active comparator | Patients receiving successful drug-coated balloon-only PCI will undergo standard dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months post-procedure, followed by single antiplatelet therapy (SAPT). Receives: Drug: 6-Month DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
NACE: at 12 Months
NACE is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
Measured: From randomization up to 12 months
Secondary outcomes (8)
NACE: at 24 Months
Composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
Measured: From randomization up to 24 months
Individual Components of NACE
Incidence of all-cause death, cardiac death, non-fatal MI (spontaneous or target-vessel MI), clinically driven TVR, and clinically driven target lesion revascularization (TLR).
Measured: Up to 12 months and 24 months
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel MI, or clinically driven TLR.
Measured: Up to 12 months and 24 months
BARC Type 2-5 and Type 3-5 Bleeding
Bleeding events defined according to Bleeding Academic Research Consortium (BARC) criteria.
Measured: Up to 12 months and 24 months
Stroke
Acute focal or global neurological deficit of vascular cause, classified as ischemic, hemorrhagic, or undetermined stroke.
Measured: Up to 12 months and 24 months
Target Lesion Thrombosis and Acute Vessel Closure
Definite or probable thrombotic occlusion or acute vessel closure within the DCB-treated segment adjudicated by DCB ARC criteria.
Measured: Up to 24 months
Medication Adherence
Rate of adherence to assigned antiplatelet therapy, temporary interruption, permanent discontinuation, and treatment crossover.
Measured: 1, 6, 12, and 24 months
Ischemic composite endpoint
First occurrence of cardiovascular death, non-fatal myocardial infarction, or ischemic stroke.
Measured: 12 months and 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KangWon National University Hospital, Korea University Guro Hospital, Hanyang University Seoul Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Gyeongsang National University Changwon Hospital, Hallym University Medical Center, Daegu Catholic University Medical Center, Severance Hospital, Ulsan Medical Center, Korea University Ansan Hospital, Pusan National University Yangsan Hospital, Inje University
- Responsible party
- Principal investigator, Eun-Seok Shin, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879430
- Sponsor's protocol ID
- UUH IRB 2026-07-039
- Acronym
- ADAPT-DCB
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention (ADAPT-DCB)
- ClinicalTrials.gov ID
- NCT07879430
- Acronym / sponsor ID
- ADAPT-DCB / UUH IRB 2026-07-039
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Dual Antiplatelet Therapy, Drug-Coated Balloon, Percutaneous Coronary Intervention, Coronary Artery Disease, Short-Term DAPT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,258 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- KangWon National University Hospital, Korea University Guro Hospital, Hanyang University Seoul Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Gyeongsang National University Changwon Hospital, Hallym University Medical Center, Daegu Catholic University Medical Center, Severance Hospital, Ulsan Medical Center, Korea University Ansan Hospital, Pusan National University Yangsan Hospital, Inje University
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 16 Oct 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.
This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). The study will evaluate net adverse clinical events (NACE) at 12 months to assess whether short-term 1-month DAPT is non-inferior to 6-month DAPT. The study is a prospective, randomized, open-label, blinded-endpoint, multicenter trial.
Detailed description
This study evaluates whether a short-term 1-month dual antiplatelet therapy (DAPT) strategy is non-inferior to the standard 6-month DAPT strategy in patients who have undergone successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI).
Patients aged 19 years or older presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who achieve successful treatment with drug-coated balloons without any permanent stent or scaffold implantation will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either 1-month DAPT followed by single antiplatelet therapy (SAPT) or standard 6-month DAPT followed by SAPT. The primary endpoint is the time to first net adverse clinical events (NACE) from randomization through 12 months, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
Secondary outcomes include individual components of NACE, target lesion failure (TLF), total bleeding events according to BARC criteria, and clinical outcomes evaluated at a pre-specified 30-day landmark analysis. Clinical events will be adjudicated by an independent Clinical Events Committee.
This is a prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE), parallel-group, non-inferiority study. If clinically indicated, antiplatelet therapy may be modified or adjusted according to the investigator's clinical judgment with proper documentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Month DAPT Group | Experimental | Drug: 1-Month DAPTPatients receiving successful drug-coated balloon-only PCI will undergo dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month post-procedure, followed by single antiplatelet therapy (SAPT). |
| 6-Month DAPT Group | Active comparator | Drug: 6-Month DAPTPatients receiving successful drug-coated balloon-only PCI will undergo standard dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months post-procedure, followed by single antiplatelet therapy (SAPT). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 DAPTPatients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month (30 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 25 and 35, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months. | Drug | 1-Month DAPT Group |
| 6-Month DAPTPatients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months (180 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 166 and 194, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months. | Drug | 6-Month DAPT Group |
Primary outcome
NACE: at 12 Months
Time frame: From randomization up to 12 months
NACE is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
8 secondary outcomes
NACE: at 24 Months
Time frame: From randomization up to 24 months
Individual Components of NACE
Time frame: Up to 12 months and 24 months
Target Lesion Failure (TLF)
Time frame: Up to 12 months and 24 months
BARC Type 2-5 and Type 3-5 Bleeding
Time frame: Up to 12 months and 24 months
Stroke
Time frame: Up to 12 months and 24 months
Target Lesion Thrombosis and Acute Vessel Closure
Time frame: Up to 24 months
Medication Adherence
Time frame: 1, 6, 12, and 24 months
Ischemic composite endpoint
Time frame: 12 months and 24 months 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 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease (CAD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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 study testing 1-Month DAPT and 6-Month DAPT in people with Coronary Artery Disease (CAD), run by Ulsan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Oct 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.
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 Eun-Seok Shin, Professor (82-52-250-5020, sesim1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE: at 12 Months (time frame: From randomization 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 16 Oct 2026.