In short
Clinical trials are studying Icosapent Ethyl in people with aortic valve stenosis and in patients after acute myocardial infarction. These studies look at whether it can help slow disease progression or reduce future cardiovascular events, while also measuring safety and other outcomes.
Key points
- Icosapent Ethyl is being studied in two authorised clinical trials with different goals. One Phase 2 study looks at people with aortic valve stenosis and measures change in aortic valve calcium over 24 months. One Phase 3 study looks at patients after acute myocardial infarction who are at high risk for another cardiovascular event. That larger study measures time to the first major heart or blood vessel event, including heart death, non-fatal heart attack, stroke, urgent coronary revascularisation, or heart failure hospitalisation. Together, these trials focus on whether Icosapent Ethyl can help with disease progression and future cardiovascular risk.
Trials at a glance
Two clinical trials are investigating Icosapent Ethyl in different patient groups. Both studies are interventional, which means the researchers give a treatment and then measure what happens. 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.
SALVAGE study in aortic valve stenosis
The SALVAGE study is a Phase 2 trial with 110 planned participants and a status of Authorised. It is studying people with aortic valve stenosis, which is a narrowing of the heart valve that can make blood flow harder. 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.
The intervention listed for this trial is Vazkepa 998 mg soft capsules, given as 4 g by oral use. 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.
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. It is studying patients with acute myocardial infarction, which means a heart attack. The study asks whether intensified residual risk management can lower the chance of later cardiovascular events compared with standard guideline treatment.
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. 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.
Who may participate
From the trial data, the SALVAGE study is for people with aortic valve stenosis. The BIO-RISK-EVENT study is for patients with acute myocardial infarction who are considered at high risk for recurrent cardiovascular events. The available source text does not give more detailed entry rules, such as age limits or lab test requirements.
Main endpoints being measured
An endpoint is the main result a trial uses to judge whether the treatment is working. In SALVAGE, the endpoint is the change in aortic valve calcium after 24 months. 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.
- Cardiovascular death means death from a heart or blood vessel problem.
- Non-fatal myocardial infarction means a heart attack that the person survives.
- Non-fatal stroke means a stroke that the person survives.
- Urgent coronary revascularisation means a procedure needed quickly to improve blood flow in the heart arteries.
- Heart failure hospitalisation means a hospital stay because the heart is not pumping well enough.
Trial phases and study design
Phase 2 trials usually explore whether a treatment shows promise and helps define the next steps in research. Phase 3 trials are larger and are used to confirm whether a treatment works in a broader group of patients. In the data provided, both studies are interventional, and the BIO-RISK-EVENT study is specifically described as randomized controlled.
The source data also shows that both trials are Authorised, meaning they have been approved to move forward in the study process. No additional details were provided about randomization or masking in the SALVAGE study.