NCT06466278

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jun 2023Dec 2026

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

June 14, 2024

Last Update Submit

September 30, 2025

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Change in aortic valve calcium (AVC) score

    continuous variable

    2 years

Study Arms (2)

Medication

EXPERIMENTAL
Drug: Icosapent ethyl

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Icosapent ethylDRUG

2dd2

Medication
PlaceboDRUG

2dd2

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years
  • Mild to moderate AVS

You may not qualify if:

  • Bicuspid aortic valve
  • History of chest radiotherapy
  • History of rheumatic fever
  • Moderate to severe renal failure, defined as eGFR \< 30 ml/min
  • Hyperparathyroidism
  • Paget's disease
  • Diagnosis of (active) malignancy in last 5 years
  • Anticipated or planned aortic valve surgery in the next 6 months
  • Life expectancy \<2 years
  • Chronic atrial fibrillation
  • Use of anticoagulant medication or dual antiplatelet therapy
  • Known hypersensitivity to fish and/or shellfish
  • Known hypersensitivity to soya
  • Malabsorption syndrome and/or chronic diarrhea
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

June 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)