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®

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546398
• Other study ID #: SYROS-DSE-BMP-01-21-EU
• Status: Completed
• Start date: April 22, 2022
• Est. completion date: November 17, 2022

Study information

• Verified date: November 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia

Intervention

Drug:
• Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab
No study drug was administered during this study.

Other:
• No study drug
No study drug was administered during this study.

Locations

Country	Name	City	State
Germany	Kardiologische Gemeinschaftspraxis (Bulut)	Arnsberg
Germany	Dr. Georg Strack	Bad König
Germany	Dr. J. Nothroff	Berlin
Germany	Kardiologie am Spreebogen (Krackhardt)	Berlin
Germany	Kardiologie Spreebogen Berlin (Haverkamp)	Berlin
Germany	Kardiologische Facharztpraxis Winkelmann	Berlin
Germany	SPK-Studienzentrum Rankestraße GmbH	Berlin
Germany	Kardio Bonn	Bonn
Germany	Dr. Jaroslaw Sek	Chemnitz
Germany	Praxis Dipl.-med. Schermaul	Chemnitz
Germany	BAG Helmecke	Crivitz
Germany	Kardiologie Darmstadt	Darmstadt
Germany	MVZ Rhein-Main GmbH (Binder)	Dreieich
Germany	Cardiologicum Dresden / Pirna (Hildebrandt)	Dresden
Germany	Facharztzentrum Dresden-Neustadt GbR (Simonis)	Dresden
Germany	PD Dr. Stephan Wiedemann	Dresden
Germany	Praxis Dr. Methfessel	Dresden
Germany	KardioPraxis Rote Straße (Stieber)	Duisburg
Germany	Kardiologische Praxis (Warzok)	Gotha
Germany	Kardiopraxis Greiz (Walter)	Greiz
Germany	MVZ des Krankenhaus Greiz	Greiz
Germany	Kardiologie am Tibarg (Twisselmann)	Hamburg
Germany	Diabetiker Zentrum Hannover (Fendler)	Hannover
Germany	Kardiologie Haßloch (Gerhards)	Haßloch
Germany	Kardiologie Alsterquelle	Henstedt-Ulzburg
Germany	Praxis Dr. Lißmann	Homburg
Germany	Praxis für Kardiologie und Schlafmedizin (Lichtenberg)	Köln
Germany	Gemeinschaftspraxis Dr. Täschner / Dr. Bonigut	Leipzig
Germany	Praxis Dr. Feige	Leipzig
Germany	Gemeinschaftspraxis Schauermann	Meiningen
Germany	Gemeinschaftspraxis Dres. med. Dittgen/Wilhelm/Rehlinger	Mettlach
Germany	Hausarztpraxis Doreen Drews	Michendorf
Germany	Hausarztpraxis Thorsten Drews	Michendorf
Germany	Kardio Praxis Mülheim (Möllenberg)	Mülheim
Germany	Dres. Bettenworth & Partner	Münster
Germany	Gemeinschaftspraxis am Jahnufer (Schleß)	Neu-Ulm
Germany	Kardiopraxis (Buchholz-Sanchez)	Neustadt
Germany	Kardiologie am Weißen Turm (Stadelmann)	Nürnberg
Germany	Praxis für Kardiologie (Laser)	Nürnberg
Germany	Dres. Kornadt und Edel	Oberhausen
Germany	Praxis Dr. Spengler	Panitzsch
Germany	Kardiologische Praxis Papenburg Dr. Denchev	Papenburg
Germany	Kardiologische Praxis Papenburg Dr. Malazhavy	Papenburg
Germany	Kardiologische Praxis Papenburg Dr. Wilke	Papenburg
Germany	MVZ ambulantes Kardiologisches Zentrum Peine gGmbH	Peine
Germany	Kardiologe im MVZ Pfaffenhofen	Pfaffenhofen an der Ilm
Germany	Hausärztlich-Kardiologisches MVZ am Felsenkeller	Pirna
Germany	Kardiologische Gemeinschaftspraxis am Park Sanssouci (Janßen)	Potsdam
Germany	Kardiologische Gemeinschaftspraxis am Park Sanssouci (Reibis)	Potsdam
Germany	Nephrocare Püttlingen GmbH	Puttlingen
Germany	Praxisklinik Salzatal	Salzatal
Germany	Praxis Dr. Jax	Schwalmtal
Germany	Parkkardiologie (Wolf)	Stahnsdorf
Germany	Parkkardiologie (Wuttke)	Stahnsdorf
Germany	Praxis Dr. Birkenhagen	Stollberg
Germany	Kardiologische Gemeinschaftspraxis Dres. Klein & Neumann	Stuttgart
Germany	Studienzentrum der Herzklinik Ulm GbR	Ulm
Germany	Nephrologisches Zentrum Villingen Schwenningen (Hohenstein)	Villingen-Schwenningen
Germany	Kardiologische Praxis (Elmas)	Waghäusel
Germany	Praxis am Gutenbergplatz	Wiesbaden
Germany	Praxis Gerschanik	Wuppertal
Germany	Dres. Herrmann/Meyer/Teschner (Meyer)	Würzburg
Germany	Praxis für Innere Medizin (Schwarz)	Zwenkau

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company	Daiichi Sankyo Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on Physician Survey	Physicians will be surveyed to assess the LDL-C levels at the time of a therapy decision.	Up to 6 months
Primary	Reductions in Low density Lipoprotein-Cholesterol (LDL-C) Levels Based on Physician Survey	Physicians will be surveyed to determine their anticipated reductions in LDL-C levels as a result of therapy.	Up to 6 months
Primary	Visual Analogue Scale (VAS) Score Evaluating Relevance of Decision Factors and Considerations Relevant to Therapy Decision Based on Physician Survey	Physicians will be surveyed to determine the relevance of decision factors and considerations (including guidelines) that were relevant to their therapy decision based on a VAS ranging from 0 to 10.	Up to 6 months
Primary	Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on a Retrospective Patient Chart Review	A retrospective patient chart review will assess the LDL-C levels at the time of a therapy decision.	Up to 6 months
Primary	Number of Participants With Pre-specified Events in Their Medical History Based on a Retrospective Patient Chart Review	A retrospective patient chart review will assess the number of participants with pre-specified events in their medical history.	Up to 6 months
Primary	Number of Participants With Specific Concomitant Diseases Based on a Retrospective Chart Review	A retrospective patient chart review will assess the number of participants with specific concomitant diseases.	Up to 6 months
Primary	Number of Participants Implementing Specific Lifestyle Modifications Based on a Retrospective Patient Chart Review	A retrospective patient chart review will assess the number of participants with specific lifestyle modifications.	Up to 6 months