Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

Hospital General Universitario Gregorio Marañon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: evolocumab; Procedure: LDL apheresis; Drug: evolocumab and LDL apheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT03429998

EVOLAFER01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups, including a placebo group

LDL apheresis

Placebo Comparator group

Description:

LDL apheresis during at least one year

Treatment:

Procedure: LDL apheresis

Evolocumab

Active Comparator group

Description:

140 mg evolocumab biweekly

Treatment:

Drug: evolocumab

LDL apheresis and evolocumab

Active Comparator group

Description:

LDL-apheresis monthly evolocumab 140 mg biweekly

Treatment:

Drug: evolocumab and LDL apheresis