E78.2
Conditions
Interventions
Group 1: Patients with high LDL and Lp (a) levels who are receiving therapy with PCSK9 inhibitors to reduce the LDL-cholesterol.
Group 2: Patients with high LDL and Lp (a) levels who are receiving sta
Sponsors
Deutsches Herzzentrum der Charite, Klinik für Kardiologie, Angiologie und Intensivmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Cardiovascular high-risk profile (existing arteriosclerotic cardiovascular disease with target LDL-C < 55 mg/dl) concomitant with a diet and in combination with a statin or with a statin and other lipid-lowering therapies - Primary hypercholesterolemia and mixed dyslipidemia: adults with hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia in addition to a diet and in combination with a statin or with a statin and other lipid-lowering therapies. other lipid-lowering therapies with evidence of arteriosclerotic disease - Familial hypercholesterolemia Accompanying a diet and in in combination with a statin or with a statin and other lipid-lowering therapies with evidence of atherosclerotic disease arteriosclerotic disease - Cardiovascular high-risk profile with LDL values above 115 mg/dl who have not previously received statin therapy.
Exclusion criteria
Exclusion criteria: - Previous therapy with PCSK9 inhibitors / synthesis inhibitors - LDL cholesterol < 55 mg/dl - Pregnancy/lactation (planned or ongoing) - Drug or alcohol abuse - Dementia or general Inability to understand the contents of the information / study - Existing treatment with lipid apheresis - Age <18 years - Contraindications for treatment with PCSK9 inhibitors according to the Information for healthcare professionals - Discontinuation of therapy with PCSK9 inhibitors by the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of thrombin generation (TG, nmol/I) under standard therapy or therapy with with PCSK9 inhibitors within approx. 3 months (+/- 2 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reduction of platelet aggregability: measurement of the decrease in platelet platelet aggregability during therapy with PCSK9 inhibitors, determined by ADP- and thrombin receptor-activated peptide (TRAP)-induced platelet aggregation. - Reduction of platelet activation markers: PSelectin and sCD40L. - Reduction of inflammatory markers: measurement of the reduction of specific inflammatory markers in in connection with the therapy using ELISA and FACS. - Change in the lipid composition of membranes: Investigation of the change in the composition of phospholipids and oxidized lipids lipids on platelets and leukocytes under therapy with PCSK9 inhibitors using mass spectroscopy and ELISA | — |
Countries
Germany
Contacts
Public ContactUrsula Rauch-Kröhnert
Deutsches Herzzentrum der Charite (DHZC), Klinik für Kardiologie, Angiologie und Intensivmedizin
Outcome results
None listed