Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

Hospital General Universitario Gregorio Marañon9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia

Interventions

evolocumabDRUG

evolocumab 140 mg/biweekly

evolocumab and LDL apheresisDRUG

evolocumab 140 mg/biweekly LDL-apheresis monthly

LDL apheresisPROCEDURE

LDL apheresis biweekly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with age\> 18 years * hypercholesterolemia with LDL-cholesterol\> 100 mg / dl in treatment with the maximum dose tolerated by statins and a history of severe cardiovascular disease * patients who are included in the LDL-apheresis / biweekly program Exclusion Criteria: * contraindications to receive evolocumab according to technical data. * hospital admission of any cause in the last three months prior to the inclusion of the study * cardiovascular event in the three months prior to the inclusion of the study * Inability to sign informed consent * pregnant women and non-menopausal women who do not use at least one adequate contraceptive method

Locations (1)

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Outcomes

Primary Outcomes

decrease in LDL-cholesterol (mg/dl)

decrease in LDL-cholesterol levels in all three phases: LDL-apheresis, evolocumab and combined

Time frame: 9 months

Secondary Outcomes

Decrease apo-B (mg/dl) levels

decrease in Apolipoprotein B levels in all three phases

Time frame: 9 months

Decrease lipoprotein A (mg/dl) levels

decrease in lipoprotein A levels in all three phases

Time frame: 9 months

Decrease in triglycerides (mg/dl) levels

Decrease in triglycerides levels in all three phases

Time frame: 9 months

any adverse effects

any serious adverse effects

Time frame: 9 months

Modification of C reactive protein

Effect of evolocumab and LDL-apheresis on C reactive protein levels (mg/l)

Time frame: 9 months

Modification of immunoglobulin G levels (mg/dl)

Effect of of evolocumab and LDL-apheresis on immunoglobulin (mg/dl)

Time frame: 9 months

Modification of immunoglobulin A levels (mg/dl)

Effect of evolocumab and LDLapheresis on immunoglobulin A (mg/dl)

Time frame: 9 months

Modification of complement levels (mg/dl)

Data from ClinicalTrials.gov

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