1 or 6 Months of Dual Antiplatelet Therapy After Drug-coated Balloon Angioplasty for De-novo Small Coronary Artery Disease

NCT07592507 | Not Yet Recruiting Phase 4

• 1 other identifier: DC25MIDI0053
• Study Type: interventional
• Target: 1,484
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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 disease.
2. 2.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.

Conditions

Coronary Artery Disease; Stable Angina Pectoris

Keywords

DAPT; aspirin; clopidogrel; drug coated balloon; DCB; dual antiplatelet therapy; small vessel disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (1)

• Secondary Validation Variables:

  1,3,6 and 12 month

Study Arms (2)

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.

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.

Drug: 1-Month DAPT followed by SAPT; Drug: 6-Month DAPT followed by SAPT

Interventions

1-Month DAPT followed by SAPT DRUG

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.

DAPT(aspirin and clopidogrel 1month); DAPT(aspirin and clopidogrel 6month)

6-Month DAPT followed by SAPT DRUG

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.

DAPT(aspirin and clopidogrel 1month); DAPT(aspirin and clopidogrel 6month)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )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

You may not qualify if:

• \) Patients diagnosed with Acute Coronary Syndrome (ACS), including STEMI, NSTEMI, or Unstable Angina.
• \) Patients undergoing concomitant Percutaneous Coronary Intervention (PCI) during the Drug-Coated Balloon (DCB) procedure.
• \) 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.
• \) Patients who underwent surgery with moderate-to-high risk within 6 weeks prior to obtaining informed consent.
• \) 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).
• \) Patients with a life expectancy of less than 1 year due to malignancy or other comorbidities.
• \) 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).
• \) Patients with dyspnea, such as those with Chronic Obstructive Pulmonary Disease (COPD).
• \) Patients with intolerance or hypersensitivity to the investigational medicinal products.
• \) Patients who participated in other clinical trials within 3 months prior to informed consent (excluding non-interventional observational studies).
• \) 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.
• \) Patients with rare hereditary metabolic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• \) Any patient deemed unsuitable for participation in the clinical trial at the investigator's discretion.

Sponsors & Collaborators

• Daejeon St. Mary's hospital: lead

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

대원 DW KIM

CONTACT

+82-42-220-9943; mirinesilver@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is an open-label trial as the duration of DAPT (1 month vs. 6 months) cannot be masked from participants and investigators. However, to ensure objectivity, an independent endpoint adjudication committee, whose members are blinded to the treatment assignment, will adjudicate all clinical endpoints. Additionally, data analysts will remain blinded to the treatment groups until the final database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): February 1, 2032
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share