Clinical trial NCT03429998: Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
Official title: Comparative Pilot Study of the Effectiveness of Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: cardiovascular risk
evolocumab
LDL-apheresis
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. Phase LDL apheresis:
2. evolocumab phase
3. Combined phase
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: decrease in LDL-cholesterol (mg/dl)
timeFrame: 9 months
Secondary outcomes:
measure: Decrease apo-B (mg/dl) levels
timeFrame: 9 months
measure: Decrease lipoprotein A (mg/dl) levels
timeFrame: 9 months
measure: Decrease in triglycerides (mg/dl) levels
timeFrame: 9 months
measure: any adverse effects
timeFrame: 9 months
measure: Modification of C reactive protein
timeFrame: 9 months
measure: Modification of immunoglobulin G levels (mg/dl)
timeFrame: 9 months
measure: Modification of immunoglobulin A levels (mg/dl)
timeFrame: 9 months
measure: Modification of complement levels (mg/dl)
timeFrame: 9 months
measure: Modification of serum fibrinogen (mg/dl)
timeFrame: 9 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Marian Goicoechea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: