Hypercholesterolemia Clinical Trial
Official title:
Comparative Pilot Study of the Effectiveness of Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.
STUDY DESIGN An open-label, prospective phase III study to compare the efficacy and safety of
administering evolocumab versus treatment with LDLapheresis in patients with familial
hypercholesterolemia and high cardiovascular risk.
STUDY POPULATION The chosen population is constituted by patients belonging to the
LDL-apheresis program of the General University Hospital Gregorio Marañón with the diagnosis
of familial hypercholesterolemia and a history of cardiovascular disease.
Number of patients expected to participate in the study according to the base of patients
treated with LDL-apheresis: 10.
STUDY DESIGN:
Non-controlled intervention study to evaluate the different therapies in the treatment of
hypercholesterolemia, in which each patient will be self-controlled. The variables will be
analyzed during different phases
1. LDL-apheresis phase: Retrospectively during the previous year, pre- and postapheresis
variables will be collected from the following lipid parameters: total cholesterol,
LDL-cholesterol, HDL-cholesterol, triglycerides, atherogenicity index, Lipoprotein A,
apo-A, apo- B; inflammatory parameters: PCR, ferritin, fibrinogen, leukocytes and
polymorphonuclear and immunological parameters: immunoglobulins and complement.
2. Evolocumab phase: LDL-apheresis will be suspended for three months and Evolocumab
administered: 140 mg / 15 days subcutaneously. The same parameters indicated in the
previous section will be measured every two weeks.
3. Combined phase: During the following three months evolocumab will continue to be
administered biweekly and the LDL-apheresis procedure will be spaced from biweekly to
monthly, the same analytical parameters being measured again every two weeks.
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