IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

Phase 2

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Drug: Icosapent ethyl; Drug: Placebo

• Registration Number: NCT06466278
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-05
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication	Icosapent ethyl	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in aortic valve calcium (AVC) score	2 years

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands