Optimal antithrombotic strategy for treatment of atherosclerotic cardiovascular disease – comparison of clopidogrel-based antiplatelet agent treatment versus aspirin plus low dose rivaroxaban therapy (OACART study)

Seoul National University Bundang Hospital0 个研究点目标入组 2,758 人开始时间: 待定最近更新: 2023年5月30日

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•1. Patients aged 65 or older with multivessel CAD 1 year after the onset of acute myocardial infarction
•2. Patients with peripheral arterial disease (PTA or bypass history, foot/lower limb amputation, intermittent disruption, ABI<0.9 or more than 50% stenosis in peripheral arteries, or more than 50% stenosis in carotid artery or carotid artery stentomy) have either a history of acute myocardial infarction or multiple CAD over one year at the same time

•1. Pregnant women and lactating women
•2. Patients with a history of allergic reactions to the following drugs or contraindications for drug use
•aspirin, clopidogrel, rivaroxaban
•3. Patients with severe renal impairment with a creatinine cleaning rate of less than 15 mL/min
•4. Patients with blood coagulation disorders or related liver diseases and patients with moderate (Child Pugh B) and severe (Child Pugh C) liver disorders
•5. Patients requiring long-term combination treatment of other anticoagulants: Unfracted Heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants, etc. are required.
•6.Active pathologic bleeding, such as peptic ulcer, tumor bleeding or intracranial hemorrhage
•7.History of major bleeding, BARC class =3, resulting in stop of antiplatelet agents within 3 months
•8.Known coagulopathy or refusal of blood transfusion
•9.Presence of non-cardiac comorbidity with life expectancy < 3 years from randomization
•10.Plan to surgery or intervention which needs to stop antiplatelet agents =3 months
•11.Conditions that may result in protocol non-compliance by the committees
•12.Co-administration of contraindicated medications as follows: other P2Y 12 inhibitors (prasugrel or ticagrelor); cytochrome P450 2C19 inhibitors (fluoxetine, moclobemid or voriconazole); probenecid; high dose of methotrexate (=15 mg/week); lithium
•13.Refusal to give written informed consent

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