Overview
Sponsor-declared trial summary
Aortic valve stenosis
To study the effect of icosapent ethyl on progression of aortic valve calcification.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 27 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517342-33-01
- EudraCT number
- 2022-002135-56
- WHO UTN
- U1111-1311-8079
- ClinicalTrials.gov
- NCT06466278
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To study the effect of icosapent ethyl on progression of aortic valve calcification.
Conditions and MedDRA coding
Aortic valve stenosis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517342-33-00 | IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion (SALVAGE) | Amsterdam UMC Stichting |
| 2024-512140-28-00 | IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion (SALVAGE) | Amsterdam UMC Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age > 50 years
- Mild to moderate aortic valve stenosis
Exclusion criteria 4
- Bicuspid aortic valve
- History of chest radiotherapy
- History of rheumatic fever
- Moderate to severe renal failure, defined as eGFR < 30 ml/min
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in aortic valve calcium (AVC) at 24 months
Secondary endpoints 4
- Change in peak aortic jet velocity at 24 months
- Change in calculated aortic valve area (AVA) at 24 months
- Total coronary plaque volume progression (mm2)
- Non-calcified coronary plaque volume progression (mm2)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9086542 · Product
- Active substance
- Icosapent Ethyl
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX06 — OMEGA-3-TRIGLYCERIDES
- Marketing authorisation
- EU/1/20/1524/001
- MA holder
- AMARIN PHARMACEUTICALS IRELAND LIMITED
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- CURIUS
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- CURIUS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 110 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-09-27 | 2024-09-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517342-33-01 | 3 |
| Recruitment arrangements (for publication) | BlankDocument | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_IcosapentEthyl | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-12 | Netherlands | Acceptable with conditions 2024-09-26
|
2024-09-26 |