None listed
Conditions
Interventions
Drug : A. Aspirin
(1) product name: no limit
(2) Company Name: Unlimited
(3) Formulation: White round intestinal preparation
(4) Composition: Aspirin 100 mg
(5) Efficacy/Effect:
? Inhibit thrombogenes
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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) | — |
Countries
Korea, Republic of
Contacts
Public Contactgahyun lee
Seoul National University Bundang Hospital
Outcome results
None listed