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Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy (OACART)

2026年8月30日 更新者:Chang-Hwan Yoon、Seoul National University Bundang Hospital

Optimal Strategy for Treatment of Atherosclerotic Cardiovascular Disease - Comparison of Clopidogrel-based Antiplatelet Agent Treatment Versus Aspirin Plus Low Dose Rivaroxaban Therapy

The study aims to conduct a randomized controlled trial among adults aged 19 years or older who have experienced acute myocardial infarction at least one year prior, or who have other comorbidities such as peripheral arterial disease or multiple cardiovascular diseases, and have consented to participate in the study. Participants will be randomly assigned to either a group that maintains antiplatelet therapy with aspirin and clopidogrel or clopidogrel alone, or a group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban in a 1:1 ratio. The study aims to demonstrate that maintaining clopidogrel-based antiplatelet therapy is not clinically inferior to maintaining combined therapy with aspirin and low-dose rivaroxaban.

調査の概要

詳細な説明

Rupture of atherosclerotic plaques and resulting thrombotic or embolic events can lead to myocardial infarction, stroke, and death. Particularly after vascular interventions such as percutaneous coronary intervention, stent implantation, or peripheral vascular interventions, it takes more than a year for the damaged endothelial cells to heal completely, leading to frequent thrombotic complications. In addition, clinically undiagnosed atrial fibrillation, stroke caused by thrombosis formation due to venous damage, myocardial infarction, deep vein thrombosis, and pulmonary embolism may occur. Therefore, drug therapy to prevent thrombosis is necessary for these patients, and many studies have been conducted to determine the optimal treatment.

Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is essential for treating patients after percutaneous coronary intervention (PCI). DAPT can minimize ischemic events not only in stent lesions but also in non-reperfused lesions of the coronary artery. However, DAPT increases the risk of bleeding, so a treatment strategy is needed to minimize ischemic events while reducing the risk of bleeding by using dual antiplatelet therapy for a short time after the procedure, administering antiplatelet drugs differently depending on the bleeding risk. In particular, in patients at high risk of bleeding (HBR), the side effects of bleeding due to long-term antiplatelet therapy are closely related to long-term survival, making this issue even more important. Compared to traditional aspirin use, the use of clopidogrel has been reported to reduce mortality, myocardial infarction, stroke, and hospitalization due to acute coronary artery disease while reducing bleeding complications.

In addition, a study has reported that combining low-dose anticoagulants with aspirin as a thromboprophylactic agent for stable atherosclerotic patients who were previously treated only with antiplatelet drugs reduces mortality and has superior effects on the prevention of myocardial infarction and stroke compared to aspirin alone. Aspirin and low-dose rivaroxaban combination therapy has been approved for use in patients with multivessel CAD who are over 65 years of age and have experienced acute myocardial infarction for more than one year, as well as patients with peripheral arterial disease (PAD) (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI <0.9, or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) who have one of the two conditions: a history of acute myocardial infarction for over one year or multivessel CAD.

Ultimately, studies comparing clopidogrel and low-dose rivaroxaban and aspirin combination therapy in similar patient populations have shown the superiority of each treatment strategy, but no studies have compared the two treatment strategies. If clopidogrel monotherapy is more convenient to take, has better compliance, and is not less effective than low-dose rivaroxaban and aspirin combination therapy, it may be considered as a more convenient treatment strategy for many patients.

研究の種類

介入

入学 (推定)

2758

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Gyeonggi-do
      • Seongnam-si、Gyeonggi-do、韓国、463-707
        • 募集
        • Seoul National Universtiy Bundang Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Patients over 65 years of age who have experienced acute myocardial infarction and have multivessel coronary artery disease (CAD) that has been present for over one year
  • Patients who have peripheral arterial disease (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI <0.9 or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) and have a history of acute myocardial infarction for over one year or have one of the two conditions: multivessel CAD.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment, and he/she or his/her legally authorized representative provides written informed consent prior to study

Exclusion Criteria:

  • History of serious hypersensitivity reactions to aspirin, clopidogrel, or prasugrel.
  • Patients with coagulation disorders or liver diseases related to coagulation, as well as patients with moderate (Child Pugh B) and severe (Child Pugh C) liver dysfunction.
  • Severe renal impairment with a creatinine clearance less than 15 mL/min.
  • Patients who require long-term combination therapy with other anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparinoids (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.).
  • In cases of active clinical bleeding at the time of study registration.
  • Patients who require discontinuation of antiplatelet therapy for more than 3 months due to surgery or procedure
  • Individuals with an expected lifespan of less than 3 years due to reasons other than cardiovascular disease.
  • Concomitant use of the following contraindicated drugs: other P2Y12 inhibitors (prasugrel or ticagrelor); cytochrome P450 2C19 inhibitors (fluoxetine, fluvoxamine, or voriconazole); probenecid; high-dose methotrexate (≥15 mg/week); lithium.
  • Pregnant or breastfeeding women.
  • Inability to provide informed consent

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Combination of antiplatelet and low-dose anticoagulant agents
A group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban
Combination of aspirin and low-dose rivaroxaban
他の名前:
  • Aspirin + low-dose rivaroxaban (2.5mg bid)
アクティブコンパレータ:Conventional use of clopidogrel-based antiplatelet therapy with or without aspirin
A group that maintains clopidogrel-based antiplatelet therapy, with or without aspirin, at the clinician's discretion
Clopidogrel-based SAPT or DAPT at the clinician's discretion
他の名前:
  • clopidogrel-based SAPT or DAPT

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
Patient oriented cardiac event
時間枠:36 months
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
36 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient oriented cardiac event in CAD only group
時間枠:36 months
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
36 months
Patient oriented cardiac event in PAD only group
時間枠:36 months
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
36 months
Composite of MI, stroke or CV death
時間枠:36 months
Myocardial infarction, stroke or cardiovascular death measured by percent of participants with adverse events
36 months
Composite of MI, stroke or CV death in CAD only group
時間枠:36 months
Myocardial infarction, stroke or cardiovascular death measured by percent of coronary disease participants with adverse events
36 months
Composite of MI, stroke or CV death in CAD and PAD group
時間枠:36 months
Myocardial infarction, stroke or cardiovascular death measured by percent of all participants with adverse events
36 months
Patency of target lesion in PAD intervention group
時間枠:36 months
Measured by percent of participants undergone repeat PTA to the previous lesion
36 months
Composite of major thrombotic events
時間枠:36 months
Cardiovascular death, MI, ischemic stroke, stent thrombosis or acute limb ischemia, venous thromboembolism (Deep vein thrombosis or pulmonary embolism)
36 months

協力者と研究者

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出版物と役立つリンク

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年11月15日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年8月27日

QC基準を満たした最初の提出物

2026年8月27日

最初の投稿 (実際)

2026年9月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月2日

QC基準を満たした最後の更新が送信されました

2026年8月30日

最終確認日

2026年8月1日

詳しくは

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