AzTrials
AzTrials

Coronary Artery DiseasePhase 4DUALCADNCT05210725

Trained Immunity by Dual-pathway Inhibition in Coronary Artery Disease

A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet in people with Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Coronary artery disease (CAD) is a manifestation of systemic atherosclerosis for which single antiplatelet therapy (SAPT) is indicated if patients are stable. Recently dual pathway inhibition (DPI) by combining a low-dose factor Xa inhibitor (rivaroxaban2.5mg twice daily) with a single platelet inhibitor (ASA) has… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Rivaroxaban 2.5 Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNetherlands
Study dates
1 Mar 2022to 1 Jul 2022
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • stable CAD
  • with an indication for single antiplatelet therapy according to international (ESC) guidelines,
  • high cardiovascular risk based on a SMART risk score [9] of at least 20% and/or the judgement of the cardiologist
  • at least 1 year after myocardial infarction or multivessel CAD
  • >16 years old
  • Written informed consent

Who cannot join

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Use of more intensive antithrombotic treatment (dual antiplatelet therapy, DPI, direct oral anticoagulants, vitamin k antagonists)
  • Use of immunosuppressant and/or anti-inflammatory therapy, including glucocorticoids, cytostatics, antibodies, immunophilins, interferons, Tumor Necrosis Factor (TNF) binding proteins, mycophenolate and interleukin antagonists
  • Contra-indication to rivaroxaban
  • Hypersensitivity to rivaroxaban
  • at significant risk for major bleeding
Show all 21Show fewer
  • current gastrointestinal ulceration
  • presence of malignant neoplasms, with the exception of non-melanoma skin cancer
  • recent (<2 months) brain or spinal injury
  • recent (<3 months) brain or spinal surgery
  • recent (<3 months) intracranial, gastrointestinal or pulmonary hemorrhage
  • presence of arteriovenous malformations,
  • major intraspinal or intracerebral vascular abnormalities
  • congenital or acquired bleeding disorders
  • uncontrolled severe arterial hypertension (180 mmHg or more systolic, or 110 mmHg or more diastolic)
  • Severe hepatic disease: Child Pugh B or C [10]
  • Severe kidney failure: estimated glomerular filtration rate<15 ml/min or requiring dialysis
  • severe heart failure with known ejection fraction < 30% or New York Heart Association class III or IV symptoms [12]
  • concomitant treatment with medication with a strong pharmacokinetic interaction with rivaroxaban, leading to contra-indication according to the "regionale_NOAC_richtlijn" [12]
  • Pregnant or breastfeeding women
  • Unable to give informed consent

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen, Gelderland, 6525GA

Other trials in Netherlands

About this study

Official title: Trained Immunity by Dual-pathway Inhibition (Low-dose Rivaroxaban and Acetylsalicylic Acid) in Coronary Artery Disease'

Coronary artery disease (CAD) is a manifestation of systemic atherosclerosis for which single antiplatelet therapy (SAPT) is indicated if patients are stable. Recently dual pathway inhibition (DPI) by combining a low-dose factor Xa inhibitor (rivaroxaban2.5mg twice daily) with a single platelet inhibitor (ASA) has been demonstrated to be beneficial in treating CAD. The exact mechanisms underlying the benefits of DPI, are not completely understood. CAD is characterised by a state of chronic low-grade inflammation, where monocytes from CAD patients have a higher immune responsiveness to ex vivo stimulation with lipopolysaccharide (LPS) compared to healthy matched controls. Surprisingly, the investigators have recently observed an elevation in ex vivo immune responsiveness to LPS stimulation when switching from ASA monotherapy to DPI of ASA combined with rivaroxaban inpatients with peripheral arterial disease (n=11; unpublished). Remarkably this was associated with no changes in systemic inflammation, as determined by Olink proteomics analysis. These findings suggest that factor Xa inhibitors can enhance immune cell responsiveness despite being clinically beneficial to CAD. The exact mechanisms contributing to the observed increased immune responsiveness remain unexplored.

Being tested
Rivaroxaban 2.5 Mg Oral Tablet
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Rivaroxaban 2.5 Mg Oral TabletDrug

    2.5 mg rivaroxaban twice a day in addition to acetylsalicylic acid (80-00mg once a day, standard care).

Study groups in NCT05210725
Study groupRoleWhat they receive
Stable coronary artery diseaseExperimentalPatients with stable coronary artery disease with an indication for single antiplatelet therapy according to international (ESC) guidelines, with a high cardiovascular risk.
Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet

What is being measured

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

  1. Whole blood immune responsiveness

    Change in whole blood immune responsiveness to lipopolysaccharide stimulation when switching from acetylsalicylic acid to dual pathway inhibition (acetylsalicylic acid and low-dose rivaroxaban).

    Measured: 12 weeks

Secondary outcomes (3)

  1. White blood cell count and distribution

    changes in white blood cell count and distribution when switching from acetylsalicylic acid to dual pathway inhibition (acetylsalicylic acid and low-dose rivaroxaban).

    Measured: 3 months

  2. Monocyte immune responsiveness

    Change in monocyte immune responsiveness to LPS stimulation when switching from acetylsalicylic acid to dual pathway inhibition (acetylsalicylic acid and low-dose rivaroxaban).

    Measured: 3 months

  3. Enrichment of epigenetic marks on genes

    Enrichment of epigenetic marks on genes when switching from acetylsalicylic acid to dual pathway inhibition (acetylsalicylic acid and low-dose rivaroxaban).

    Measured: 3 months

Timeline

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

  1. First posted27 Jan 2022
  2. Study start1 Mar 2022
  3. Primary completion15 Apr 2022
  4. Study completion1 Jul 2022 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05210725
Sponsor's protocol ID
NL2021-13291
Acronym
DUALCAD
Status last verified
Jan 2022
First submitted
13 Jan 2022
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Groh LA, Willems LH, Fintelman P, Reijnen MMPJ, El Messaoudi S, Warle MC. Dual-Pathway Inhibition with Rivaroxaban and Low-Dose Aspirin Does Not Alter Immune Cell Responsiveness and Distribution in Patients with Coronary Artery Disease. Cardiol Ther. 2024 Mar;13(1):233-242. doi: 10.1007/s40119-023-00342-5. Epub 2023 Dec 6.

    PubMed 38055176

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet in people with Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.

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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. 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 Netherlands. 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?

Results are not available in the source record.

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?

Whole blood immune responsiveness (time frame: 12 weeks). 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 NCT05210725, 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 20 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in