Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

Sponsor
Hospital General Universitario Gregorio Marañon
Study ID
NCT03429998
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 1, 2017
Status verified
Feb 2018
Primary completion
Jan 28, 2018
Completion
Jan 28, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: LDL apheresis
    LDL apheresis during at least one year
  • Active Comparator: Evolocumab
    140 mg evolocumab biweekly
  • Active Comparator: LDL apheresis and evolocumab
    LDL-apheresis monthly evolocumab 140 mg biweekly

Primary Outcome Measure

decrease in LDL-cholesterol (mg/dl) [ Time Frame: 9 months ]

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