IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion
NCT ID: NCT06466278
Last Updated: 2025-10-03
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2023-06-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Medication
Icosapent ethyl
2dd2
Placebo
Placebo
2dd2
Interventions
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Icosapent ethyl
2dd2
Placebo
2dd2
Eligibility Criteria
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Inclusion Criteria
2. Mild to moderate AVS
Exclusion Criteria
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
50 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Matthijs Boekholdt
Principal investigator
Locations
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Academic Medical Center
Amsterdam, , Netherlands
Countries
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Other Identifiers
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NL81780.018.22
Identifier Type: -
Identifier Source: org_study_id
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