Effects of aSPIrin versus aspirin plus low-dose RIvaroxaban on carotid aTherosclerotic Plaque inflammation

Asan Medical Center0 个研究点目标入组 92 人开始时间: 待定最近更新: 2023年4月4日

试验速览

暂无简介。

•1) Men or women at least 18 years of age inclusive
•2) Asymptomatic carotid artery disease (diameter stenosis, 20-80%)
•3) Inclusion criteria for the COMPASS trial (stable PAD; or stable CAD with 1 of age?65 years, or age <65 years plus atherosclerosis = 2 vascular beds or = 2 additional risk factors)
•Additional risk factors
•?Current smoker
•?Diabetes Mellitus
•?Renal dysfunction,estimated glomerular filtration rate <60 ml/min
•?Heart failure
•?Non-lacunar ischemic stroke =within 1month
•4) FDG PET/CT shows hot uptakes at carotid artery (TBR = 1.6)
•5) The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the Institutional Review Board/Ethical Committee.

•1) Patients treated with carotid endarterectomy or stent placement
•2) Contraindications to rivaroxaban or aspirin.
•3) Stroke ?1 month or any hemorrhagic or lacuna stroke
•4) Need for dual antiplatelet therapy or oral anticoagulant therapy
•5) Severe left ventricular dysfunction (ejection fraction < 30%)
•6) Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
•7) Diabetes patients currently under insulin therapy.
•8) 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.
•9) Patient’s pregnant or breast-feeding or child-bearing potential.
•10) Patients who have experienced critical organ bleeding within 1 year
•11) Unwillingness or inability to comply with the procedures described in this protocol.

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