1 or 6 Months of Dual Antiplatelet Therapy After Drug-coated Balloon Angioplasty for De-novo Small Coronary Artery Disease (D-ONE)
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：대원 DW KIM
- 電話番号：+82-42-220-9943
- メール：mirinesilver@catholic.ac.kr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
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.
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アクティブコンパレータ：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. |
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Primary Validation Variables
時間枠：Up to 12 months
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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.
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Up to 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Secondary Validation Variables:
時間枠：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, |
1,3,6 and 12 month
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DC25MIDI0053
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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