IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

NL81780.018.22

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

2023-06-01

2026-07-01

2026-12-01

Recruiting

Early phase I

110

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}

2024-06-19