Status:
COMPLETED
Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 car...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03429998
Start Date
April 1 2017
End Date
January 28 2018
Last Update
February 12 2018
Active Locations (1)
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1
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007