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)
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008458
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 2758
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 36month later, patient oriented cardiac event (All-cause death, Any MI, Any stroke, Any revascularization (CAD or PAD), acute limb ischemia, any acute thromboembolism and ISTH Major bleeding events
- Secondary Outcome Measures
Name Time Method -Composite of MI, stroke or CV death -Composite of MI, stroke or CV death in CAD only group -Composite of MI, stroke or CV death in CAD and PAD group -Patency of target lesion in PAD intervention group -Composite of major thrombotic events ?Cardiovascular death, MI, ischemic stroke, stent thrombosis or acute limb ischemia ?Venous thromboembolism (Deep vein thrombosis or pulmonary embolism)