Table of Contents
- Trials at a glance
- SALVAGE study in aortic valve stenosis
- BIO-RISK-EVENT study after acute myocardial infarction
- Who may participate
- Main endpoints being measured
- Trial phases and study design
Trials at a glance
Two clinical trials are investigating Icosapent Ethyl in different patient groups.[1][2] Both studies are interventional, which means the researchers give a treatment and then measure what happens.[1][2] One trial focuses on aortic valve stenosis, and the other focuses on patients after acute myocardial infarction who are at high risk for more cardiovascular events.[1][2]
SALVAGE study in aortic valve stenosis
The SALVAGE study is a Phase 2 trial with 110 planned participants and a status of Authorised.[1] It is studying people with aortic valve stenosis, which is a narrowing of the heart valve that can make blood flow harder.[1] The brief summary says the study is looking at the effect of Icosapent Ethyl on the progression of aortic valve calcification, meaning calcium buildup in the valve.[1]
The intervention listed for this trial is Vazkepa 998 mg soft capsules, given as 4 g by oral use.[1] The main endpoint is the change in aortic valve calcium at 24 months, which helps show whether the valve disease is getting worse more slowly.[1]
BIO-RISK-EVENT study after acute myocardial infarction
The BIO-RISK-EVENT Study is a Phase 3 randomized controlled trial with 1,758 planned participants and a status of Authorised.[2] It is studying patients with acute myocardial infarction, which means a heart attack.[2] The study asks whether intensified residual risk management can lower the chance of later cardiovascular events compared with standard guideline treatment.[2]
This study includes Icosapent Ethyl as Vazkepa 998 mg soft capsules, and it also lists empagliflozin and colchicine as additional drugs in the intervention plan.[2] The main endpoint is the time to the first event in a composite of cardiovascular outcomes, which means several serious heart and blood vessel events are grouped together in one main result.[2]
Who may participate
From the trial data, the SALVAGE study is for people with aortic valve stenosis.[1] The BIO-RISK-EVENT study is for patients with acute myocardial infarction who are considered at high risk for recurrent cardiovascular events.[2] The available source text does not give more detailed entry rules, such as age limits or lab test requirements.[1][2]
Main endpoints being measured
An endpoint is the main result a trial uses to judge whether the treatment is working.[1][2] In SALVAGE, the endpoint is the change in aortic valve calcium after 24 months.[1] In BIO-RISK-EVENT, the endpoint is time to the first major cardiovascular event, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalisation for urgent coronary revascularisation, or hospitalisation for heart failure.[2]
- Cardiovascular death means death from a heart or blood vessel problem.[2]
- Non-fatal myocardial infarction means a heart attack that the person survives.[2]
- Non-fatal stroke means a stroke that the person survives.[2]
- Urgent coronary revascularisation means a procedure needed quickly to improve blood flow in the heart arteries.[2]
- Heart failure hospitalisation means a hospital stay because the heart is not pumping well enough.[2]
Trial phases and study design
Phase 2 trials usually explore whether a treatment shows promise and helps define the next steps in research.[1] Phase 3 trials are larger and are used to confirm whether a treatment works in a broader group of patients.[2] In the data provided, both studies are interventional, and the BIO-RISK-EVENT study is specifically described as randomized controlled.[1][2]
The source data also shows that both trials are Authorised, meaning they have been approved to move forward in the study process.[1][2] No additional details were provided about randomization or masking in the SALVAGE study.[1]
