Investigational product: Evolocumab.
Repatha®® is a human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Phase II. Pilot study.
Primary objective: to assess if LDL-C lowering at 1 year with monthly subcutaneous (SC) evolocumab 420 mg for 1 year will result in a significant reduction of high-sensitivity troponin T (hs-TnT), surrogate marker of myocyte injury and atherosclerosis progression, compared with current standard of care (SOC) in subjects with elevated LDL-C, stable coronary artery disease (CAD) and stable heart failure with reduced ejection fraction (HFrEF).
Study design: open-label randomized pilot study to evaluate the impact of evolocumab at 1 year follow-up on the levels of high-sensitivity troponin T (hs-TnT). Patients (N=56) will be randomized 1:1 (28:28).
Study primary end point: Change in hs-TnT levels at 1 year
Population: Patients?18 and ?80 years of age with stable CAD, NYHA class II, LDL >=70mg/dL, under statin treatment, left ventricular ejection fraction <40%. Subject participation duration: Patients will be under experimental treatment 12 months but after that in month 13th a contact phone by safety will be perform. Study duration: 40 months