Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

• Status: Completed
• Trial end date: 2018-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital General Universitario Gregorio Marañon
• Treatments: Antibodies, Monoclonal; Evolocumab

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