Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inf… (NCT05797376) | Clinical Trial Compass
CompletedPhase 4
Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inflammation
South Korea92 participantsStarted 2021-08-24
Plain-language summary
Primary Study Objective : To compare the effects of low-dose rivaroxaban plus aspirin versus aspirin on atherosclerotic plaque inflammation using serial FDG Positron Emission Tomography/Computed Tomography(PET-CT) imaging of carotid artery and ascending aorta.
Secondary Study Objective : To compare the effects of low-dose rivaroxaban plus aspirin versus aspirin on biomarkers including high-sensitivity C-Reactive Protein(CRP) and lipid profiles.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
The percent change (%) in Most Diseased segment(MDS) Target-to-Background Ratio(TBR) of the index vessel