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®
1 other identifier
observational
500
1 country
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Shorter than P25 for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2022
CompletedFirst Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2022
CompletedDecember 1, 2022
November 1, 2022
7 months
September 14, 2022
November 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
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
Study Arms (2)
Physicians
Office-based cardiologists (OBCs) and lipid management specialists (LMSs) who are qualified for study participation regarding experience in lipid management therapy and treating a sufficient number of patients.
High and Very High Cardiovascular Patients
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 bempedoic acid 180 mg fixed dose combination with ezetimibe 10 mg (FDC).
Interventions
No study drug was administered during this study.
Eligibility Criteria
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.
You may qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
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
Praxis für Kardiologie und Schlafmedizin (Lichtenberg)
Cologne, 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)
Hanover, Germany
Kardiologie Haßloch (Gerhards)
Haßloch, Germany
Kardiologie Alsterquelle
Henstedt-Ulzburg, Germany
Praxis Dr. Lißmann
Homburg, 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)
Nuremberg, Germany
Praxis für Kardiologie (Laser)
Nuremberg, 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
Püttlingen, 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, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 19, 2022
Study Start
April 22, 2022
Primary Completion
November 17, 2022
Study Completion
November 17, 2022
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share