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

Sponsor
Daejeon St. Mary's hospital
Study ID
NCT07592507
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Coronary Artery Disease
  • Stable Angina Pectoris

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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. 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. 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. 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.

Key Dates

First listed
May 18, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Feb 29, 2032
Completion
Feb 29, 2032

Study Design

Enrollment
1,484 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DAPT(aspirin and clopidogrel 1month)
    Experimental Group (1-Month DAPT: Aspirin + Clopidogrel) Initial Phase (1 Month): Aspirin 100 mg and Clopidogrel 75 mg administered orally once daily.
  • Active Comparator: DAPT(aspirin and clopidogrel 6month)
    Control Group (6-Month DAPT: Aspirin + Clopidogrel) Initial Phase (6 Months): Aspirin 100 mg and Clopidogrel 75 mg administered orally once daily.

Primary Outcome Measure

Primary Validation Variables [ Time Frame: Up to 12 months ]

Central Contacts

Related Studies