CClinicalTrials.gg
Active, not recruitingNCT06466278SALVAGEUpdated Oct 3, 2025

IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

A Phase 2 interventional study of Icosapent ethyl and Placebo in Aortic Valve Stenosis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Active, not recruiting at 1 site in Netherlands. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
  • Registered 1 year after the study started (first participant enrolled Jun 2023, registered Jun 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

This study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.

02

Conditions studied

  • Aortic Valve Stenosis

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03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 110 is close to the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age > 50 years
  2. Mild to moderate AVS

Exclusion criteria

Exclusion Criteria:

  1. Bicuspid aortic valve
  2. History of chest radiotherapy
  3. History of rheumatic fever
  4. Moderate to severe renal failure, defined as eGFR \< 30 ml/min
  5. Hyperparathyroidism
  6. Paget's disease
  7. Diagnosis of (active) malignancy in last 5 years
  8. Anticipated or planned aortic valve surgery in the next 6 months
  9. Life expectancy \<2 years
  10. Chronic atrial fibrillation
  11. Use of anticoagulant medication or dual antiplatelet therapy
  12. Known hypersensitivity to fish and/or shellfish
  13. Known hypersensitivity to soya
  14. Malabsorption syndrome and/or chronic diarrhea
  15. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study.
  16. Women who are pregnant or breastfeeding
  17. Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
  18. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Medication

    Drug: Icosapent ethyl

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugIcosapent ethyl

    2dd2

  • DrugPlacebo

    2dd2

06

What researchers measure

Primary outcomes

  1. Change in aortic valve calcium (AVC) score

    continuous variable

    Time frame: 2 years

07

Study locations

1 site
  • Academic Medical Center
    Amsterdam, 1105AZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06466278
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Matthijs Boekholdt (Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Jun 20, 2024
Start date
Jun 1, 2023
Primary completion
Jul 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Oct 3, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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