Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
NCT ID: NCT03429998
Last Updated: 2018-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
9 participants
INTERVENTIONAL
2017-04-01
2018-01-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
1. Phase LDL apheresis:
2. evolocumab phase
3. Combined phase
TREATMENT
NONE
Study Groups
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LDL apheresis
LDL apheresis during at least one year
LDL apheresis
LDL apheresis biweekly
Evolocumab
140 mg evolocumab biweekly
evolocumab
evolocumab 140 mg/biweekly
LDL apheresis and evolocumab
LDL-apheresis monthly evolocumab 140 mg biweekly
evolocumab and LDL apheresis
evolocumab 140 mg/biweekly LDL-apheresis monthly
Interventions
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evolocumab
evolocumab 140 mg/biweekly
evolocumab and LDL apheresis
evolocumab 140 mg/biweekly LDL-apheresis monthly
LDL apheresis
LDL apheresis biweekly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Marían Goicoechea
MD, PhD
Principal Investigators
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Marian Goicoechea, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Locations
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Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Countries
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Other Identifiers
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EVOLAFER01
Identifier Type: -
Identifier Source: org_study_id
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