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Atherosclerosis of ArteryPhase 4SPIRITNCT05797376

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

A Phase 4 study testing Rivaroxaban 2.5mg in people with Atherosclerosis of Artery and Coronary Artery Disease, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban 2.5mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteSouth Korea
Study dates
24 Aug 2021to 5 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

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.

Read the detailed description

Cardiovascular disease is a major health problem across the world. The age-adjusted death rate for cardiovascular disease has significantly decreased during recent decades, and this decline is related to the widespread use of evidence-based medicines. However, even upon optimal medical therapies, patients remains at a substantial residual risk for acute coronary syndrome (ACS) or acute ischemic stroke(AIS), requiring new therapeutic approaches. Plaque rupture and subsequent thrombus formation is the most common cause of ACS and AIS. Atherosclerosis is a chronic immune-inflammatory disorder. Inflammation is believed to be critically important to plaque rupture by destroying the fibrous cap, thereby predisposing to ACS and AIS. Cross-talk between coagulation and inflammatory pathway via protease-activated receptor (PAR) activation has been recognized . Factor Xa is responsible for promoting inflammation, which participate in the atherosclerotic process and plaque destabilization either directly via activation of PARs or indirectly through the generation of thrombin .

In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial, the rate of a composite of cardiovascular death, stroke, or myocardial infarction was lower by 24% with low-dose rivaroxaban (2.5 mg twice daily) plus aspirin than with aspirin alone among patients with stable atherosclerotic vascular disease, but the rate of major bleeding was higher by 70%. Interestingly, the rate of stroke was remarkably lower by 42% with rivaroxaban plus aspirin than with aspirin alone. The substantial net clinical benefits seen with rivaroxaban plus aspirin may not be fully explained by their anti-thrombotic effect alone, suggesting pleiotropic effects coupled with factor Xa antagonism. Besides its role in hemostasis and thrombosis, low-dose rivaroxaban may inhibit atherosclerotic plaque inflammation and decrease plaque destabilization. To test this hypothesis, the investigators will compare the effects of aspirin versus aspirin plus low-dose rivaroxaban on carotid atherosclerotic plaque inflammation using serial 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography(PET-CT) imaging of carotid artery and ascending aorta.

Being tested
Rivaroxaban 2.5mg
Medical subject headings
Coronary Artery Disease, Peripheral Arterial Disease, Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban 2.5mgDrug

    Also called Xarelto 2.5mg

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

Study groups in NCT05797376
Study groupRoleWhat they receive
Rivaroxaban + Aspirin groupExperimentalpatients are prescribed aspirin at a daily dose of 100mg and Rivaroxaban (2.5 mg twice a day)
Receives: Drug: Rivaroxaban 2.5mg
Aspirin groupNo interventionpatients are prescribed aspirin at a daily dose of 100mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (2)

  1. 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.

    Measured: 12 months

  2. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start24 Aug 2021
  3. Primary completion12 Nov 2024
  4. Study completion5 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797376
Sponsor's protocol ID
2020-1322
Acronym
SPIRIT
Status last verified
Dec 2024
First submitted
9 Mar 2023
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim TO, Han S, Ryu J, Lee JB, Suh CH, Wee SB, Kang SJ, Moon DH, Lee CW, Gwon JG, Lee SW; SPIRIT Investigators. Effect of low-dose rivaroxaban plus aspirin on 18F-FDG PET/CT-detectable carotid plaque inflammation: a randomized trial. Eur Heart J Cardiovasc Imaging. 2026 Sep 1;27(9):1728-1740. doi: 10.1093/ehjci/jeag176.

    PubMed 42439277

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban 2.5mg in people with Atherosclerosis of Artery and Coronary Artery Disease, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percent change (%) in Most Diseased segment(MDS) Target-to-Background Ratio(TBR) of the index vessel (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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