Hypercholesterolemia Clinical Trial
Official title:
Comparative Pilot Study of the Effectiveness of Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
Verified date | February 2018 |
Source | Hospital General Universitario Gregorio Marañon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | January 28, 2018 |
Est. primary completion date | January 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañon | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario Gregorio Marañon |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | decrease in LDL-cholesterol (mg/dl) | decrease in LDL-cholesterol levels in all three phases: LDL-apheresis, evolocumab and combined | 9 months | |
Secondary | Decrease apo-B (mg/dl) levels | decrease in Apolipoprotein B levels in all three phases | 9 months | |
Secondary | Decrease lipoprotein A (mg/dl) levels | decrease in lipoprotein A levels in all three phases | 9 months | |
Secondary | Decrease in triglycerides (mg/dl) levels | Decrease in triglycerides levels in all three phases | 9 months | |
Secondary | any adverse effects | any serious adverse effects | 9 months | |
Secondary | Modification of C reactive protein | Effect of evolocumab and LDL-apheresis on C reactive protein levels (mg/l) | 9 months | |
Secondary | Modification of immunoglobulin G levels (mg/dl) | Effect of of evolocumab and LDL-apheresis on immunoglobulin (mg/dl) | 9 months | |
Secondary | Modification of immunoglobulin A levels (mg/dl) | Effect of evolocumab and LDLapheresis on immunoglobulin A (mg/dl) | 9 months | |
Secondary | Modification of complement levels (mg/dl) | Effect of evolocumab and LDL apheresis on serum complement (mg/dl) | 9 months | |
Secondary | Modification of serum fibrinogen (mg/dl) | Effect of evolocumab and LDL-apheresis on serum fibrinogen (mg/dl) | 9 months |
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