1-Month DAPT followed by SAPT
DrugAspirin 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.
NCT Number: NCT07592507
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 1,3,6 and 12 month
[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,
Contact information is provided by the study sponsor or research team.
Daejeon St. Mary's hospital
Other
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
Acronym: D-ONE
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