Clinical trial NCT05546398: SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®
Official title: SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI® (Fixed Dose Combination of Bempedoic Acid 180mg and Ezetimibe 10mg) as add-on to Treatment With Maximally Tolerated Statin Therapy in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Mixed Dyslipidemia
Keywords: Hypercholesterolemia
Mixed dyslipidemia
NUSTENDI®
Statin therapy
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Germany
First posted: 2022-09-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the physician survey, office-based cardiologists and lipid management specialists must be qualified for study participation regarding experience in lipid management therapy and treating a sufficient number of patients. The office-based cardiologists and lipid management specialists will be preselected by the Medical Science Liaison Managers of DSDE.

The retrospective patient chart review will include patients at high and very high cardiovascular risk as assessed by the office-based cardiologists and lipid management specialists with hypercholesterolemia or mixed dyslipidemia who received a prescription of FDC for at least 4 weeks.

Brief summary: In this study, a survey of office-based cardiologists and lipid management specialists will be conducted on treatment decisions for NUSTENDI® (bempedoic acid 180 mg fixed dose combination \[FDC\] with ezetimibe 10 mg) followed by a retrospective chart review of patients at high and very-high cardiovascular risk with hypercholesterolemia or mixed dyslipidemia who were treated with FDC as add-on to treatment with maximally tolerated statin therapy in routine clinical practice.

Detailed description: The physician survey aims to understand the context of the real-world clinical setting and shed light on the utilization of FDC treatments by the prescribing physicians. The retrospective patient chart review will gain insights in real-world data of the patient's characteristics with a treatment decision for the FDC. No study drugs will be provided or administered as part of this protocol.

The objectives of the physician survey are the evaluation of the key factors for the therapy decision for the FDC:

* LDL-C levels at therapy decision and goal of LDL-C reduction
* Relevance of different factors and considerations
* Considerations of guidelines

The objectives of the retrospective patient chart review are to characterize the patients':

* Demographics
* LDL-C levels at therapy decisions
* Medical History
* Concomitant Diseases
* Lifestyle Modifications

Eligibility criteria: Inclusion Criteria:

* Eligibility criteria for the office-based cardiologists and lipid management specialists are as follows:

  * More than 10 years of experience in medical practice
  * For office-based cardiologists: Supervision of at least 200 patients at high and very high cardiovascular risk as assessed by the office-based cardiologists with hypercholesterolemia or mixed dyslipidemia. For lipid management specialists: Supervision of at least 500 patients at high and very high cardiovascular risk as assessed by the lipid management specialists with hypercholesterolemia or mixed dyslipidemia
  * Working in practices to whom patients were either referred or had direct access to.
  * Availability to share medical files of consenting patients with study personnel (e.g. Clinical Research Associates) by remote quality review
  * At least 5 patients for the retrospective chart review

The inclusion criteria for the patients are as follows:

* Written informed consent to participate
* Patients at high and very high cardiovascular risk diagnosed with hypercholesterolemia or mixed dyslipidemia and treated with bempedoic acid 180 mg fixed dose combination with ezetimibe 10 mg (FDC) for at least 4 weeks at the discretion of the physician according to the German label

Exclusion Criteria:

* Any patient who did not meet all inclusion criteria noted above

Primary outcomes:
measure: Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on Physician Survey
timeFrame: Up to 6 months
measure: Reductions in Low density Lipoprotein-Cholesterol (LDL-C) Levels Based on Physician Survey
timeFrame: Up to 6 months
measure: Visual Analogue Scale (VAS) Score Evaluating Relevance of Decision Factors and Considerations Relevant to Therapy Decision Based on Physician Survey
timeFrame: Up to 6 months
measure: Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on a Retrospective Patient Chart Review
timeFrame: Up to 6 months
measure: Number of Participants With Pre-specified Events in Their Medical History Based on a Retrospective Patient Chart Review
timeFrame: Up to 6 months
measure: Number of Participants With Specific Concomitant Diseases Based on a Retrospective Chart Review
timeFrame: Up to 6 months
measure: Number of Participants Implementing Specific Lifestyle Modifications Based on a Retrospective Patient Chart Review
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Kardiologische Gemeinschaftspraxis (Bulut)
city: Bad König
country: Germany
facility: Dr. Georg Strack
city: Berlin
country: Germany
facility: Dr. J. Nothroff
city: Berlin
country: Germany
facility: Kardiologie am Spreebogen (Krackhardt)
city: Berlin
country: Germany
facility: Kardiologie Spreebogen Berlin (Haverkamp)
city: Berlin
country: Germany
facility: Kardiologische Facharztpraxis Winkelmann
city: Berlin
country: Germany
facility: SPK-Studienzentrum Rankestraße GmbH
city: Bonn
country: Germany
facility: Kardio Bonn
city: Chemnitz
country: Germany
facility: Dr. Jaroslaw Sek
city: Chemnitz
country: Germany
facility: Praxis Dipl.-med. Schermaul
city: Crivitz
country: Germany
facility: BAG Helmecke
city: Darmstadt
country: Germany
facility: Kardiologie Darmstadt
city: Dreieich
country: Germany
facility: MVZ Rhein-Main GmbH (Binder)
city: Dresden
country: Germany
facility: Cardiologicum Dresden / Pirna (Hildebrandt)
city: Dresden
country: Germany
facility: Facharztzentrum Dresden-Neustadt GbR (Simonis)
city: Dresden
country: Germany
facility: PD Dr. Stephan Wiedemann
city: Dresden
country: Germany
facility: Praxis Dr. Methfessel
city: Duisburg
country: Germany
facility: KardioPraxis Rote Straße (Stieber)
city: Gotha
country: Germany
facility: Kardiologische Praxis (Warzok)
city: Greiz
country: Germany
facility: Kardiopraxis Greiz (Walter)
city: Greiz
country: Germany
facility: MVZ des Krankenhaus Greiz
city: Hamburg
country: Germany
facility: Kardiologie am Tibarg (Twisselmann)
city: Hannover
country: Germany
facility: Diabetiker Zentrum Hannover (Fendler)
city: Haßloch
country: Germany
facility: Kardiologie Haßloch (Gerhards)
city: Henstedt-Ulzburg
country: Germany
facility: Kardiologie Alsterquelle
city: Homburg
country: Germany
facility: Praxis Dr. Lißmann
city: Köln
country: Germany
facility: Praxis für Kardiologie und Schlafmedizin (Lichtenberg)
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Täschner / Dr. Bonigut
city: Leipzig
country: Germany
facility: Praxis Dr. Feige
city: Meiningen
country: Germany
facility: Gemeinschaftspraxis Schauermann
city: Mettlach
country: Germany
facility: Gemeinschaftspraxis Dres. med. Dittgen/Wilhelm/Rehlinger
city: Michendorf
country: Germany
facility: Hausarztpraxis Doreen Drews
city: Michendorf
country: Germany
facility: Hausarztpraxis Thorsten Drews
city: Mülheim
country: Germany
facility: Kardio Praxis Mülheim (Möllenberg)
city: Münster
country: Germany
facility: Dres. Bettenworth & Partner
city: Neu-Ulm
country: Germany
facility: Gemeinschaftspraxis am Jahnufer (Schleß)
city: Neustadt
country: Germany
facility: Kardiopraxis (Buchholz-Sanchez)
city: Nürnberg
country: Germany
facility: Kardiologie am Weißen Turm (Stadelmann)
city: Nürnberg
country: Germany
facility: Praxis für Kardiologie (Laser)
city: Oberhausen
country: Germany
facility: Dres. Kornadt und Edel
city: Panitzsch
country: Germany
facility: Praxis Dr. Spengler
city: Papenburg
country: Germany
facility: Kardiologische Praxis Papenburg Dr. Denchev
city: Papenburg
country: Germany
facility: Kardiologische Praxis Papenburg Dr. Malazhavy
city: Papenburg
country: Germany
facility: Kardiologische Praxis Papenburg Dr. Wilke
city: Peine
country: Germany
facility: MVZ ambulantes Kardiologisches Zentrum Peine gGmbH
city: Pfaffenhofen an der Ilm
country: Germany
facility: Kardiologe im MVZ Pfaffenhofen
city: Pirna
country: Germany
facility: Hausärztlich-Kardiologisches MVZ am Felsenkeller
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci (Janßen)
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci (Reibis)
city: Puttlingen
country: Germany
facility: Nephrocare Püttlingen GmbH
city: Salzatal
country: Germany
facility: Praxisklinik Salzatal
city: Schwalmtal
country: Germany
facility: Praxis Dr. Jax
city: Stahnsdorf
country: Germany
facility: Parkkardiologie (Wolf)
city: Stahnsdorf
country: Germany
facility: Parkkardiologie (Wuttke)
city: Stollberg
country: Germany
facility: Praxis Dr. Birkenhagen
city: Stuttgart
country: Germany
facility: Kardiologische Gemeinschaftspraxis Dres. Klein & Neumann
city: Ulm
country: Germany
facility: Studienzentrum der Herzklinik Ulm GbR
city: Villingen-Schwenningen
country: Germany
facility: Nephrologisches Zentrum Villingen Schwenningen (Hohenstein)
city: Waghäusel
country: Germany
facility: Kardiologische Praxis (Elmas)
city: Wiesbaden
country: Germany
facility: Praxis am Gutenbergplatz
city: Wuppertal
country: Germany
facility: Praxis Gerschanik
city: Würzburg
country: Germany
facility: Dres. Herrmann/Meyer/Teschner (Meyer)
city: Zwenkau
country: Germany
facility: Praxis für Innere Medizin (Schwarz)
Study officials:
References: