Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inflammation (SPIRIT)
Atherosclerosis of Artery, Coronary Artery Disease, Peripheral Arterial Disease
About this trial
This is an interventional prevention trial for Atherosclerosis of Artery
Eligibility Criteria
Inclusion Criteria: Men or women at least 18 years of age inclusive Asymptomatic Carotid Artery Disease (diameter stenosis, 20-80%) Inclusion criteria for the COMPASS trial (stable Peripheral Artery Disease(PAD); or stable Coronary Artery Disease(CAD) with 1 of age over 65 years, or age <65 years plus atherosclerosis less than 2 vascular beds or less than 2 additional risk factors) FDG Postron Emission Tomography(PET)/Computed tomogrphy(CT) shows hot uptakes at carotid artery (with or without hot uptake at ascending aorta) The patient or guardian agrees to the study protocol and the schedule of clinical and FDG Postron Emission Tomography(PET)/Computed tomogrphy(CT) follow-up, and provides informed, written consent, as approved by the Institutional Review Board/Ethical Committee. Exclusion Criteria: Patients treated with carotid endarterectomy or stent placement Contraindications to rivaroxaban or aspirin. Stroke in 1 month or any hemorrhagic or lacuna stroke Need for dual antiplatelet therapy or oral anticoagulant therapy Severe left ventricular dysfunction (ejection fraction < 30%) Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine aminotransferase(ALT) or aspartate aminotransferase(AST) > 3 times upper limit of normal). Unwillingness or inability to comply with the procedures described in this protocol. Patient's pregnant or breast-feeding or child-bearing potential. Insulin requiring diabetes Patients who have experienced critical organ bleeding within 1 year
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Rivaroxaban + Aspirin group
Aspirin group
patients are prescribed aspirin at a daily dose of 100mg and Rivaroxaban (2.5 mg twice a day)
patients are prescribed aspirin at a daily dose of 100mg