Clinical trial • Phase IV • Cardiology

ICOSAPENT ETHYL for Aortic valve stenosis

Phase IV trial of ICOSAPENT ETHYL for Aortic valve stenosis. 110 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Aortic valve stenosis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-09-2024
First CTIS Authorization Date
26-09-2024

Trial design

Phase IV trial across 1 site in Netherlands.

Target Sample Size
110
Trial Duration For Participant
730

Eligibility

Recruits 110 Vulnerable population not selected (isVulnerablePopulationSelected = false); no special consent or assent handling described in the available data..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected = false); no special consent or assent handling described in the available data.

Inclusion criteria

  • {"criterion_text":"-Age > 50 years\n-Mild to moderate aortic valve stenosis"}

Exclusion criteria

  • {"criterion_text":"-Bicuspid aortic valve\n-History of chest radiotherapy\n-History of rheumatic fever\n-Moderate to severe renal failure, defined as eGFR < 30 ml/min"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Change in aortic valve calcium (AVC) at 24 months","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-Change in peak aortic jet velocity at 24 months","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Change in calculated aortic valve area (AVA) at 24 months","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Total coronary plaque volume progression (mm2)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Non-calcified coronary plaque volume progression (mm2)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
110
Recruitment Window Months
37
Consent Approach
Informed consent obtained from participants; specific consent/assent procedures, age-specific documents, and languages are not described in the available data (a Subject Information and Informed Consent Form document is listed but content not provided).

Geography

Total Number Of Sites
1
Total Number Of Participants
110

Netherlands

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
26-09-2024
Processing Time Days
1
Number Of Sites
1
Number Of Participants
110

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Cardiology
Contact Person Name
Matthijs Boekholdt
Contact Person Email
s.m.boekholdt@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Vazkepa 998 mg soft capsules
Active Substance
ICOSAPENT ETHYL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation present (EU/1/20/1524/001)
Dose Levels
Max daily dose 4 g; capsule strength 998 mg (as stated in product data)
Maximum Dose
4 g per day

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