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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005515

Enrollment

Registered

2020-10-21

Start date

2021-08-24

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental:aspirin (100mg/day, PO, QD plus low-dose rivaroxaban 2.5mg, PO,BID) active comparator:aspirin (100mg/day, PO, QD)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

Measure	Time frame
MDS: most diseased segment, TBR: target-to-background ratio	—

Secondary

Measure	Time frame
Change from baseline in whole vessel TBR within the index vessel, MDS TBR, & whole vessel TBR of the aorta. Change from baseline in hs-CRP and lipid profiles	—

Countries

Korea, Republic of

Contacts

Public ContactSeungbin Park

Asan Medical Center

tmdqls0101@naver.com+82-2-2045-3396

Outcome results