Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

Study Overview
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Brief Summary
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This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.

Detailed Description
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The study is purely observational, and will document data from the patient charts only. Treatment of patients will not be changed by this study, and all clinical decisions (including on frequency of visits) will be upon the discretion of the physician. No blood samples must be taken solely for the purpose of the study. The registry will include two types of centers: 1) office-based cardiologists and 2) specialized lipid ambulances (outpatient departments). Data on patient disease and treatment history will be collected a first documentation (retrospectively). The documentation time is 3 years per patient. After the baseline visit, patients are followed-up every 6 ± 2months (last visit at month 36). This interval is considered narrow enough not to miss important events (safety reporting, cardiovascular events, hospitalizations). Patients with stable (maintenance) lipid-lowering therapy (including those with existing PCSK9i therapy) or those with any therapy changes (including newly initiated PCSK9i treatment) will be documented in this study. Compared to the former group with stable drug treatment, the latter group will likely have major LDL-C changes during the first few weeks, which will be accounted for by (retrospective) monthly documentation in the first 3 months (data will be documented at the 6-month visit. The documentation periods will be substantially longer than in the controlled studies of the PCSK9i (endpoints were as early as 3 months), and thus will provide much-needed information about the long-term effects on LDL-C and other lipid parameters, safety, and drug retention rates. Longer follow-up periods would likely be compromised by high rates of (administrative) discontinuation rates.

Official Title
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Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

Conditions
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Dyslipoproteinemias

Intervention / Treatment
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* Drug: PCSK9 Inhibitor [EPC]
* Drug: Standard lipid lowering therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or with heterozygous familial or non- familial hypercholesterolemia or mixed dyslipidemia with therapy refractory course maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis) confirmed vascular disease other risk factors for cardiovascular events Exclusion Criteria: Concurrent participation of the patient in a clinical randomised study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard lipid lowering therapy<br>Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents) | Drug: Standard lipid lowering therapy<br>* drug use according to the respective product labelling<br>* Other names: Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids;|
| PCSK9 Inhibitor [EPC]<br>Evolocumab or alirocumab. | Drug: PCSK9 Inhibitor [EPC]<br>* drug use according to the respective product labelling<br>* Other names: Repatha, Praluent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol goal achievement | < 70 mg/dl | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol reduction | Compared to baseline | up top 3 years | 
| Number of treatment changes | During the follow-up period | up to 3 years |