A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
Launched by NOVARTIS PHARMACEUTICALS · May 3, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well a new treatment called Inclisiran (Leqvio®) works for lowering cholesterol, especially in patients who are already taking a statin, which is a common cholesterol-lowering medication. The study will track different groups of patients: those starting oral lipid-lowering treatments along with statins, those starting Inclisiran, and those using Inclisiran along with a procedure called lipoprotein apheresis, which helps remove bad cholesterol from the blood. The goal is to see how these treatments perform in real-life healthcare settings.
To participate, patients must be at least 18 years old and provide consent to join the study. They need to have certain heart conditions and be newly prescribed either Inclisiran or other oral cholesterol medications. Importantly, patients who have used specific cholesterol treatments in the past or have certain health conditions may not be eligible. Participants will receive their treatment as part of their routine care, and their health will be monitored throughout the study. This trial is currently recruiting participants and aims to gather valuable information on how these cholesterol-lowering treatments work for different patients.
Gender
ALL
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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Augsburg, , Germany
Essen, , Germany
Hamburg, , Germany
Kiel, , Germany
Koeln, , Germany
Jena, , Germany
Lüneburg, , Germany
Muenster, , Germany
Heidelberg, , Germany
Dresden, , Germany
Markkleeberg, , Germany
Passau, , Germany
Konstanz, Baden Wuerttemberg, Germany
Dachau, Bayern, Germany
Landshut, Bayern, Germany
Cloppenburg, , Germany
Ingelheim, , Germany
Offenbach, , Germany
Bad Nauheim, , Germany
Dresden, , Germany
Nuernberg, , Germany
Ulm, , Germany
Kirchheim, Baden Wuerttemberg, Germany
Leipzig, Sachsen, Germany
Hennigsdorf, , Germany
Trier, , Germany
Dachau, , Germany
München, , Germany
Oranienburg, , Germany
Berlin, , Germany
Chemnitz, , Germany
Dessau Roßlau, , Germany
Hassloch, , Germany
Königsbrück, , Germany
Muehlheim An Der Ruhr, , Germany
Mannheim, , Germany
Aachen, , Germany
Berlin, , Germany
Greifswald, , Germany
Bad Homburg, , Germany
Berlin, , Germany
Darmstadt, , Germany
Kassel, , Germany
Papenburg, , Germany
Riesa, , Germany
Wermsdorf, , Germany
Moers, , Germany
Kaiserslautern, Rheinland Pfalz, Germany
Emmendingen, , Germany
Neuruppin, , Germany
Münster, , Germany
Naumburg, , Germany
Halle Saale, , Germany
Oschatz, , Germany
Zwiesel, , Germany
Rostock, , Germany
Altenburg, , Germany
Halle S, , Germany
Fuerth, , Germany
Speyer, , Germany
Ludwigshafen, , Germany
Lutherstadt Wittenberg, , Germany
Muehldorf, , Germany
Schwedt, , Germany
Stadtlohn, , Germany
Cologne, , Germany
Guenzburg, , Germany
Hohenstein Ernstthal, , Germany
Rendsburg, , Germany
Detmold, Nrw, Germany
Brueel, , Germany
Wismar, , Germany
Chemnitz, Saxony, Germany
Ehringshausen, , Germany
Frechen, , Germany
Ehingen, , Germany
Freudenstadt, Baden Wuerttemberg, Germany
Muenchen, Bavaria, Germany
Stralsund, Mecklenburg Vorpommern, Germany
Kaiserslautern, Rhineland Palatinate, Germany
Eberswalde, Saxony, Germany
Leipzig, Saxony, Germany
Pirna, Saxony, Germany
Hamburg, , Germany
Morsbach, , Germany
Pirmasens, , Germany
Salzatal, , Germany
Wesel, , Germany
Villingen Schwenningen, , Germany
Kirchheim, Baden Wuerttemberg, Germany
Coburg, Bavaria, Germany
Wuerzburg, Bavaria, Germany
Potsdam, Brandenburg, Germany
Gorlitz, Saxony, Germany
Siegen, Westfalia, Germany
Borsdorf, , Germany
Gruenwald, , Germany
Halle, , Germany
Heide, , Germany
Nürnberg, , Germany
Zwenkau, , Germany
Muenster, Northrhine Westfalia, Germany
Winsen, Lower Saxony, Germany
Muenchen, Bavaria, Germany
Burg, Brandenburg, Germany
Brilon, , Germany
Greiz, , Germany
Neumarkt, , Germany
Marktoberdorf, Bavaria, Germany
Rotenburg, Lower Saxony, Germany
Munchen, , Germany
Deggendorf, Bavaria, Germany
Bayreuth, , Germany
Aue, , Germany
Coburg, Bavaria, Germany
Bad Salzuflen, Northrhine Westfalia, Germany
Quedlinburg, Saxony Anhalt, Germany
Greiz, Thueringen, Germany
Mainz, , Germany
Landshut, Bavaria, Germany
Koeln, , Germany
Biedenkopf, , Germany
Schwandorf, , Germany
Hachenburg, , Germany
Eisfeld, , Germany
Viersen, , Germany
Witten, North Rhine Westphalia, Germany
Chemnitz, Saxonia, Germany
Osnabrueck, , Germany
Olpe, , Germany
Winterberg, , Germany
Fussen, , Germany
Konstanz, Baden Wuerttemberg, Germany
Lueneburg, , Germany
Hohenstein Ernstthal, , Germany
Koenigsbrueck, , Germany
Munster, , Germany
Wuppertal, , Germany
Heidelberg, Baden Wuerttemberg, Germany
Koenigsbrueck, , Germany
Dessau Rosslau, , Germany
Kirchheim Unter Teck, Baden Wuerttemberg, Germany
Fuessen, Bayern, Germany
Gruenwald, Bayern, Germany
Kassel, Hessen, Germany
Bad Salzuflen, Nordrhein Westfalen, Germany
Ingelheim, Rheinland Pfalz, Germany
Halle Saale, Sachsen Anhalt, Germany
Eberswalde, Sachsen, Germany
Goerlitz, Sachsen, Germany
Hohenstein Ernstthal, Sachsen, Germany
Cuxhaven, , Germany
Aachen, Nordrhein Westfalen, Germany
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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