Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT03429998
- Lead Sponsor
- Hospital General Universitario Gregorio Marañon
- 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.
- 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 and high cardiovascular risk.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LDL apheresis and evolocumab evolocumab and LDL apheresis LDL-apheresis monthly evolocumab 140 mg biweekly LDL apheresis LDL apheresis LDL apheresis during at least one year Evolocumab evolocumab 140 mg evolocumab biweekly
- Primary Outcome Measures
Name Time Method decrease in LDL-cholesterol (mg/dl) 9 months decrease in LDL-cholesterol levels in all three phases: LDL-apheresis, evolocumab and combined
- Secondary Outcome Measures
Name Time Method Modification of immunoglobulin A levels (mg/dl) 9 months Effect of evolocumab and LDLapheresis on immunoglobulin A (mg/dl)
Decrease in triglycerides (mg/dl) levels 9 months Decrease in triglycerides levels in all three phases
Modification of immunoglobulin G levels (mg/dl) 9 months Effect of of evolocumab and LDL-apheresis on immunoglobulin (mg/dl)
Decrease apo-B (mg/dl) levels 9 months decrease in Apolipoprotein B levels in all three phases
Decrease lipoprotein A (mg/dl) levels 9 months decrease in lipoprotein A levels in all three phases
any adverse effects 9 months any serious adverse effects
Modification of serum fibrinogen (mg/dl) 9 months Effect of evolocumab and LDL-apheresis on serum fibrinogen (mg/dl)
Modification of C reactive protein 9 months Effect of evolocumab and LDL-apheresis on C reactive protein levels (mg/l)
Modification of complement levels (mg/dl) 9 months Effect of evolocumab and LDL apheresis on serum complement (mg/dl)
Trial Locations
- Locations (1)
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain