Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

NCT03429998 | Completed Phase 3 DMC

• 1 other identifier: EVOLAFER01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

cardiovascular risk; evolocumab; LDL-apheresis

Outcome Measures

Primary Outcomes (1)

• decrease in LDL-cholesterol (mg/dl)

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

  9 months

Secondary Outcomes (9)

• Decrease apo-B (mg/dl) levels

  9 months

• Decrease lipoprotein A (mg/dl) levels

  9 months

• Decrease in triglycerides (mg/dl) levels

  9 months

• any adverse effects

  9 months

• Modification of C reactive protein

  9 months

Study Arms (3)

LDL apheresis

PLACEBO COMPARATOR

LDL apheresis during at least one year

Procedure: LDL apheresis

Evolocumab

ACTIVE COMPARATOR

140 mg evolocumab biweekly

Drug: evolocumab

LDL apheresis and evolocumab

ACTIVE COMPARATOR

LDL-apheresis monthly evolocumab 140 mg biweekly

Drug: evolocumab and LDL apheresis

Interventions

evolocumab DRUG

evolocumab 140 mg/biweekly

Evolocumab

evolocumab and LDL apheresis DRUG

evolocumab 140 mg/biweekly LDL-apheresis monthly

LDL apheresis and evolocumab

LDL apheresis PROCEDURE

LDL apheresis biweekly

LDL apheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• contraindications to receive evolocumab according to technical data.
• Inability to sign informed consent
• pregnant women and non-menopausal women who do not use at least one adequate contraceptive method

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marian Goicoechea, MD, PhD

  Hospital General Universitario Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 12, 2018
• Study Start: April 1, 2017
• Primary Completion: January 28, 2018
• Study Completion: January 28, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)