STRENGTH 2015.

Trial name or title	A long‐term outcomes study to assess statin residual risk reduction with EpaNova in high cardiovascular risk patients with hypertriglyceridemia (STRENGTH)
Methods	RCT
Participants	Adult patients with hypertriglyceridaemia and low HDL and high risk for CVD
Interventions	Each for 3‐5 years: Arm 1: omega‐3 carboxylic acid capsule (Epanova, not less than 800 mg/g) and statin (once daily) Arm 2: corn oil placebo capsule and statin (once daily)
Outcomes	Primary: time to first occurrence of any component of the composite MACE (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularisation, hospitalisation for unstable angina) Secondary: composite measure of cardiovascular events that include the first occurrence of cardiovascular death, nonfatal MI and non‐fatal stroke; composite measure of coronary events that include the first occurrence of cardiac death; first occurrence of individual components of MACE; time to cardiovascular death. Other measures include: all cause mortality, new atrial fibrillation, thrombotic events, heart failure events
Starting date	Trial Registration entry: 2 April 2014 Trial start date: October 2014 Estimated study completion: November 2019
Contact information	AstraZeneca Clinical Study Information Centre, information.center@astrazeneca.com. PIs Steven Nissen (Cleveland Clinic), Michael Lincoff (Cleveland Clinic) Stephen Nicholls (Adelaide Clinical Research)
Notes	NCT02104817 EudraCT: 2014−001069−28