Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia
Research type
Research Study
Full title
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)
IRAS ID
151954
Contact name
Mark Caulfield
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-001069-28
Research summary
This research study, sponsored by AstraZeneca AB, is testing the investigational drug, Epanova. Epanova is being evaluated for the treatment of patients with high triglyceride levels and who have or are at high risk for Cardiovascular Disease (CVD).
Triglycerides are a type of fat found in the blood that the body uses for energy. The level of triglycerides that can be measured from the blood is determined by inheritance, diet and exercise. When triglycerides are maintained at normal levels, they are not an issue. However, they can cause health problems if levels become too high. High triglyceride levels can contribute to the risk of developing heart disease, high cholesterol, diabetes, high blood pressure and Coronary Artery Disease (CAD). CAD is the narrowing or blockage of the arteries around the heart. It is usually caused by a hardening or clogging of the arteries from the build-up of fatty deposits on the inner walls of the arteries. These deposits can lead to the restricting of blood flow to the heart muscle and can also be the location for blood clot formation that can result in a heart attack (myocardial infarction [MI]). When other blood vessels outside of the heart have these changes a stroke can occur. Combined, these are part of a group of diseases called Cardiovascular Disease (CVD).
The main purpose of the study is to investigate whether taking the investigational product drug, Epanova, together with standard Statin therapy reduces the risk of what are known as ‘Major Adverse Cardiovascular Events’ (MACE) when compared to taking the Statin with 'inactive' corn oil, in patients with persistently high levels of triglycerides in their blood. Eligible patients will receive an equal chance of being assigned to the group given Epanova (with their standard Statin) or the group given corn oil (with their standard Statin).
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1193
Date of REC Opinion
18 Aug 2014
REC opinion
Further Information Favourable Opinion