Coronary Artery Disease Clinical Trial
— SPIRITOfficial title:
Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inflammation
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.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center | Bayer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percent change (%) in Most Diseased segment(MDS) Target-to-Background Ratio(TBR) of the index vessel | The percent change (%) in Most Diseased segment(MDS) Target-to-Background Ratio(TBR) of the index vessel defined as (Most Diseased segment(MDS) Target-to-Background Ratio(TBR) at 12 months - Most Diseased segment(MDS) Target-to-Background Ratio(TBR) at baseline)/(Most Diseased segment(MDS) Target-to-Background Ratio(TBR) at baseline)*100.
* Index vessel: carotid artery with the highest 18-FDG uptake at baseline |
12 months | |
Secondary | Change from baseline in whole vessel Target-to-Background Ratio(TBR) | Change from baseline in whole vessel Target-to-Background Ratio(TBR) within the index vessel, Most Diseased segment(MDS) Target-to-Background Ratio(TBR), & whole vessel Target-to-Background Ratio(TBR) of the aorta. | 12 months | |
Secondary | Change from baseline in hs-C-Ractive Protein(CRP) and lipid profiles | Change from baseline in hs-C Ractive Protein(CRP) in mg/dL and lipid profiles(total cholesterol in mg/dL, Triglyceride(TG) in mg/dL, High Density Lipoprotein(HDL) in mg/dL, Low Density Lipoprotein(LDL) in mg/dL) | 12 months |
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