Study Description
This is a multicenter, non-randomized, non-interventional three-cohort study with
prospective collection of primary data of treatment with newly initiated oral Lipid
lowering treatment on top of a statin (Oral LLT cohort), newly initiated Inclisiran
(Inclisiran cohort) and newly initiated Inclisiran on top of lipid apheresis (Apheresis
plus Inclisiran cohort) in routine clinical care. All procedures, treatment adaptions and
laboratory assessments are part of clinicla routine and conducted independent of this
study.
Interventions
Inclisiran
Eligibility Criteria
Inclusion Criteria:
1. Patients who provide written informed consent to participate in the study
2. Male or female patients ≥ 18 years of age
3. Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid
lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid,
cholestyraimin)
4. Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted
reimbursement criteria or individual access requirements who are not at LDL-C goal
as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al.,
2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly
or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).
Exclusion Criteria:
1. Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
2. Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
3. Contraindication for Inclisiran according to the SmPC
4. Patients who have received Inclisiran previously
5. Patients with homozygous FH
6. Any underlying known disease, or surgical, physical, or medical condition that, in
the opinion of the investigator (or delegate) might interfere with interpretation of
the clinical study results.
7. Simultaneous or planned participation in an interventional research study
Novartis Investigative Site
Recruiting
Berlin,10178,Germany
Novartis Investigative Site
Recruiting
Mannheim,68165,Germany
Novartis Investigative Site
Recruiting
Marktoberdorf,Bavaria,87616,Germany
Novartis Investigative Site
Recruiting
Dessau-Roßlau,06846,Germany
Novartis Investigative Site
Recruiting
Olpe,57462,Germany
Novartis Investigative Site
Recruiting
Kaiserslautern,Rhineland-Palatinate,67655,Germany
Novartis Investigative Site
Recruiting
Hamburg,22087,Germany
Novartis Investigative Site
Recruiting
Freudenstadt,Baden Wuerttemberg,72250,Germany
Novartis Investigative Site
Recruiting
Speyer,67346,Germany
Novartis Investigative Site
Recruiting
Augsburg,86150,Germany
Novartis Investigative Site
Recruiting
Koeln,50670,Germany
Novartis Investigative Site
Recruiting
Wuerzburg,Bavaria,97080,Germany
Novartis Investigative Site
Recruiting
Greifswald,17475,Germany
Novartis Investigative Site
Recruiting
Chemnitz,09116,Germany
Novartis Investigative Site
Recruiting
Munchen,81925,Germany
Novartis Investigative Site
Recruiting
Winsen,Lower Saxony,21423,Germany
Novartis Investigative Site
Recruiting
Ulm,89081,Germany
Novartis Investigative Site
Recruiting
Rendsburg,24768,Germany
Novartis Investigative Site
Recruiting
Pirna,Saxony,01796,Germany
Novartis Investigative Site
Recruiting
Hennigsdorf,16761,Germany
Novartis Investigative Site
Recruiting
Muenchen,Bavaria,80331,Germany
Novartis Investigative Site
Recruiting
Berlin,10789,Germany
Novartis Investigative Site
Recruiting
Markkleeberg,04416,Germany
Novartis Investigative Site
Recruiting
Hamburg,22459,Germany
Novartis Investigative Site
Recruiting
Dresden,01129,Germany
Novartis Investigative Site
Recruiting
Oranienburg,16515,Germany
Novartis Investigative Site
Recruiting
Chemnitz,09130,Germany
Novartis Investigative Site
Recruiting
Wuppertal,42289,Germany
Novartis Investigative Site
Recruiting
Konstanz,Baden Wuerttemberg,78464,Germany
Novartis Investigative Site
Recruiting
Stadtlohn,48703,Germany
Novartis Investigative Site
Recruiting
Augsburg,86156,Germany
Novartis Investigative Site
Recruiting
Leipzig,04103,Germany
Novartis Investigative Site
Recruiting
Stralsund,Mecklenburg Vorpommern,18435,Germany
Novartis Investigative Site
Recruiting
Greiz,D-07973,Germany
Novartis Investigative Site
Recruiting
Naumburg,06618,Germany
Novartis Investigative Site
Recruiting
Hohenstein Ernstthal,09337,Germany
Novartis Investigative Site
Recruiting
Viersen,41749,Germany
Novartis Investigative Site
Recruiting
Riesa,01589,Germany
Novartis Investigative Site
Recruiting
Greiz,Thueringen,07937,Germany
Novartis Investigative Site
Recruiting
Muenchen,Bavaria,80939,Germany
Novartis Investigative Site
Recruiting
Berlin,12489,Germany
Novartis Investigative Site
Recruiting
Moers,47441,Germany
Novartis Investigative Site
Recruiting
Quedlinburg,Saxony Anhalt,06484,Germany
Novartis Investigative Site
Recruiting
Hamburg,22607,Germany
Novartis Investigative Site
Recruiting
Ehingen,89584,Germany
Novartis Investigative Site
Recruiting
Oschatz,04758,Germany
Novartis Investigative Site
Recruiting
Leipzig,04158,Germany
Novartis Investigative Site
Recruiting
Zwiesel,94227,Germany
Novartis Investigative Site
Recruiting
Kirchheim,Baden-Wuerttemberg,73230,Germany
Novartis Investigative Site
Recruiting
Trier,54292,Germany
Novartis Investigative Site
Recruiting
Bad Homburg,61348,Germany
Novartis Investigative Site
Recruiting
Witten,North Rhine-WestPhalia,58455,Germany
Novartis Investigative Site
Recruiting
Gruenwald,82031,Germany
Novartis Investigative Site
Recruiting
Cloppenburg,49661,Germany
Novartis Investigative Site
Recruiting
Neumarkt,92318,Germany
Novartis Investigative Site
Recruiting
Siegen,Westfalia,57072,Germany
Novartis Investigative Site
Recruiting
Ingelheim,55218,Germany
Novartis Investigative Site
Recruiting
Wermsdorf,04779,Germany
Novartis Investigative Site
Recruiting
Rostock,18107,Germany
Novartis Investigative Site
Recruiting
Muehldorf,84453,Germany
Novartis Investigative Site
Recruiting
Berlin,12627,Germany
Novartis Investigative Site
Recruiting
Chemnitz,Saxony,09113,Germany
Novartis Investigative Site
Recruiting
Hamburg,22769,Germany
Novartis Investigative Site
Recruiting
Eisfeld,98673,Germany
Novartis Investigative Site
Recruiting
Osnabrueck,49080,Germany
Novartis Investigative Site
Recruiting
Ludwigshafen,67071,Germany
Novartis Investigative Site
Recruiting
Coburg,Bavaria,96450,Germany
Novartis Investigative Site
Recruiting
Ulm,89073,Germany
Novartis Investigative Site
Recruiting
Bad Nauheim,61231,Germany
Novartis Investigative Site
Recruiting
Neuruppin,16816,Germany
Novartis Investigative Site
Recruiting
Bad Salzuflen,Northrhine Westfalia,32105,Germany
Novartis Investigative Site
Recruiting
Guenzburg,89312,Germany
Novartis Investigative Site
Recruiting
Dachau,85221,Germany
Novartis Investigative Site
Recruiting
Aachen,52062,Germany
Novartis Investigative Site
Recruiting
Jena,07740,Germany
Novartis Investigative Site
Recruiting
Wesel,46485,Germany
Novartis Investigative Site
Recruiting
Salzatal,D-06198,Germany
Novartis Investigative Site
Recruiting
Muehlheim An Der Ruhr,45468,Germany
Novartis Investigative Site
Recruiting
Burg,Brandenburg,03096,Germany
Novartis Investigative Site
Recruiting
Biedenkopf,35216,Germany
Novartis Investigative Site
Recruiting
Eberswalde,Saxony,16225,Germany
Novartis Investigative Site
Recruiting
Hassloch,67454,Germany
Novartis Investigative Site
Recruiting
Essen,45136,Germany
Novartis Investigative Site
Recruiting
Papenburg,26871,Germany
Novartis Investigative Site
Recruiting
Bayreuth,85445,Germany
Novartis Investigative Site
Recruiting
Lutherstadt Wittenberg,06886,Germany
Novartis Investigative Site
Recruiting
Deggendorf,Bavaria,94469,Germany
Novartis Investigative Site
Recruiting
Ulm,89077,Germany
Novartis Investigative Site
Recruiting
Nuernberg,90402,Germany
Novartis Investigative Site
Recruiting
Muenster,48149,Germany
Novartis Investigative Site
Recruiting
Halle Saale,06120,Germany
Novartis Investigative Site
Recruiting
Dachau,D-85221,Germany
Novartis Investigative Site
Recruiting
Altenburg,04600,Germany
Novartis Investigative Site
Recruiting
Kassel,34121,Germany
Novartis Investigative Site
Recruiting
Winterberg,59955,Germany
Novartis Investigative Site
Recruiting
Schwandorf,92421,Germany
Novartis Investigative Site
Recruiting
Brilon,59929,Germany
Novartis Investigative Site
Recruiting
Muenchen,80634,Germany
Novartis Investigative Site
Recruiting
Potsdam,Brandenburg,14473,Germany
Novartis Investigative Site
Recruiting
Passau,94032,Germany
Novartis Investigative Site
Recruiting
Gorlitz,Saxony,02827,Germany
Novartis Investigative Site
Recruiting
Heidelberg,69115,Germany
Novartis Investigative Site
Recruiting
Fuerth,90766,Germany
Novartis Investigative Site
Recruiting
Berlin,10115,Germany
Novartis Investigative Site
Recruiting
Mainz,55126,Germany
Novartis Investigative Site
Recruiting
Landshut,Bavaria,84034,Germany
Novartis Investigative Site
Recruiting
Darmstadt,64287,Germany
Novartis Investigative Site
Recruiting
Offenbach,63065,Germany
Novartis Investigative Site
Recruiting
Detmold,NRW,32756,Germany
Novartis Investigative Site
Recruiting
Halle,D-06108,Germany
Novartis Investigative Site
Recruiting
Schwedt,16303,Germany
Novartis Investigative Site
Recruiting
Aue,08280,Germany
Novartis Investigative Site
Recruiting
Kiel,24105,Germany
Novartis Investigative Site
Recruiting
Wismar,23966,Germany
Novartis Investigative Site
Recruiting
Brueel,19412,Germany
Novartis Investigative Site
Recruiting
Rotenburg,Lower Saxony,27356,Germany
Novartis Investigative Site
Recruiting
Fussen,87629,Germany
Novartis Investigative Site
Recruiting
Pirmasens,D-66954,Germany
Novartis Investigative Site
Recruiting
Leipzig,Saxony,04317,Germany
Novartis Investigative Site
Recruiting
Heide,25746,Germany
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.