IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

NCT ID: NCT06466278

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-12-01

Brief Summary

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

Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Medication

Group Type EXPERIMENTAL

Icosapent ethyl

Intervention Type DRUG

2dd2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2dd2

Interventions

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Icosapent ethyl

2dd2

Intervention Type DRUG

Placebo

2dd2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Matthijs Boekholdt

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Academic Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL81780.018.22

Identifier Type: -

Identifier Source: org_study_id

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