Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inflammation

NCT05797376 | Completed Phase 4 DMC

• 1 other identifier: 2020-1322
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis of Artery; Coronary Artery Disease; Peripheral Arterial Disease; Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in whole vessel Target-to-Background Ratio(TBR)

  12 months

• Change from baseline in hs-C-Ractive Protein(CRP) and lipid profiles

  12 months

Study Arms (2)

Rivaroxaban + Aspirin group

EXPERIMENTAL

patients are prescribed aspirin at a daily dose of 100mg and Rivaroxaban (2.5 mg twice a day)

Drug: Rivaroxaban 2.5mg

Aspirin group

NO INTERVENTION

patients are prescribed aspirin at a daily dose of 100mg

Interventions

Rivaroxaban 2.5mg DRUG

patients are prescribed aspirin at a daily dose of 100mg and Rivaroxaban (2.5 mg twice a day)

Also known as: Xarelto 2.5mg

Rivaroxaban + Aspirin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women at least 18 years of age inclusive
• Asymptomatic Carotid Artery Disease (diameter stenosis, 20-80%)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Bayer: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease; Carotid Stenosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 4, 2023
• Study Start: August 24, 2021
• Primary Completion: November 12, 2024
• Study Completion: December 5, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)