HypercholesterolemiaNCT05546398
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®
An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 63 sites in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab and No study drug
- How many people
- 500 participants
- Where
- 63 sitesGermany
- Study dates
- 22 Apr 2022to 17 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Any patient who did not meet all inclusion criteria noted above
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
Germany63 sites
Kardiologische Gemeinschaftspraxis (Bulut)
Arnsberg
Dr. Georg Strack
Bad König
Dr. J. Nothroff
Berlin
Kardiologie am Spreebogen (Krackhardt)
Berlin
Kardiologie Spreebogen Berlin (Haverkamp)
Berlin
Kardiologische Facharztpraxis Winkelmann
Berlin
SPK-Studienzentrum Rankestraße GmbH
Berlin
Kardio Bonn
Bonn
Dr. Jaroslaw Sek
Chemnitz
Praxis Dipl.-med. Schermaul
Chemnitz
Praxis für Kardiologie und Schlafmedizin (Lichtenberg)
Cologne
BAG Helmecke
Crivitz
Kardiologie Darmstadt
Darmstadt
MVZ Rhein-Main GmbH (Binder)
Dreieich
Cardiologicum Dresden / Pirna (Hildebrandt)
Dresden
Facharztzentrum Dresden-Neustadt GbR (Simonis)
Dresden
PD Dr. Stephan Wiedemann
Dresden
Praxis Dr. Methfessel
Dresden
KardioPraxis Rote Straße (Stieber)
Duisburg
Kardiologische Praxis (Warzok)
Gotha
Kardiopraxis Greiz (Walter)
Greiz
MVZ des Krankenhaus Greiz
Greiz
Kardiologie am Tibarg (Twisselmann)
Hamburg
Diabetiker Zentrum Hannover (Fendler)
Hanover
Kardiologie Haßloch (Gerhards)
Haßloch
Kardiologie Alsterquelle
Henstedt-Ulzburg
Praxis Dr. Lißmann
Homburg
Gemeinschaftspraxis Dr. Täschner / Dr. Bonigut
Leipzig
Praxis Dr. Feige
Leipzig
Gemeinschaftspraxis Schauermann
Meiningen
Gemeinschaftspraxis Dres. med. Dittgen/Wilhelm/Rehlinger
Mettlach
Hausarztpraxis Doreen Drews
Michendorf
Hausarztpraxis Thorsten Drews
Michendorf
Kardio Praxis Mülheim (Möllenberg)
Mülheim
Dres. Bettenworth & Partner
Münster
Gemeinschaftspraxis am Jahnufer (Schleß)
Neu-Ulm
Kardiopraxis (Buchholz-Sanchez)
Neustadt
Kardiologie am Weißen Turm (Stadelmann)
Nuremberg
Praxis für Kardiologie (Laser)
Nuremberg
Dres. Kornadt und Edel
Oberhausen
Praxis Dr. Spengler
Panitzsch
Kardiologische Praxis Papenburg Dr. Denchev
Papenburg
Kardiologische Praxis Papenburg Dr. Malazhavy
Papenburg
Kardiologische Praxis Papenburg Dr. Wilke
Papenburg
MVZ ambulantes Kardiologisches Zentrum Peine gGmbH
Peine
Kardiologe im MVZ Pfaffenhofen
Pfaffenhofen an der Ilm
Hausärztlich-Kardiologisches MVZ am Felsenkeller
Pirna
Kardiologische Gemeinschaftspraxis am Park Sanssouci (Janßen)
Potsdam
Kardiologische Gemeinschaftspraxis am Park Sanssouci (Reibis)
Potsdam
Nephrocare Püttlingen GmbH
Püttlingen
Praxisklinik Salzatal
Salzatal
Praxis Dr. Jax
Schwalmtal
Parkkardiologie (Wolf)
Stahnsdorf
Parkkardiologie (Wuttke)
Stahnsdorf
Praxis Dr. Birkenhagen
Stollberg
Kardiologische Gemeinschaftspraxis Dres. Klein & Neumann
Stuttgart
Studienzentrum der Herzklinik Ulm GbR
Ulm
Nephrologisches Zentrum Villingen Schwenningen (Hohenstein)
Villingen-Schwenningen
Kardiologische Praxis (Elmas)
Waghäusel
Praxis am Gutenbergplatz
Wiesbaden
Praxis Gerschanik
Wuppertal
Dres. Herrmann/Meyer/Teschner (Meyer)
Würzburg
Praxis für Innere Medizin (Schwarz)
Zwenkau
About this study
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
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.
Read the 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
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia
- Being tested
- Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab, No study drug
- Keywords
- Hypercholesterolemia, Mixed dyslipidemia, NUSTENDI®, Statin therapy
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic Acid 180Mg/Ezetimibe 10Mg TabDrug
Also called NUSTENDI®
No study drug was administered during this study.
No study drugOther
No study drug was administered during this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No study drug | |
| 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). Receives: Drug: Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start22 Apr 2022
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546398
- Sponsor's protocol ID
- SYROS-DSE-BMP-01-21-EU
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05546398
- Acronym / sponsor ID
- SYROS-DSE-BMP-01-21-EU
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- Hypercholesterolemia, Mixed dyslipidemia, NUSTENDI®, Statin therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Germany
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: No study drugOffice-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 | – | Drug: Bempedoic Acid 180Mg/Ezetimibe 10Mg TabPatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Eligibility criteria for the office-based cardiologists and lipid management specialists 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
Key exclusion criteria (1 listed)
- Any patient who did not meet all inclusion criteria noted above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic Acid 180Mg/Ezetimibe 10Mg TabAlso: NUSTENDI®No study drug was administered during this study. | Drug | High and Very High Cardiovascular Patients |
| No study drugNo study drug was administered during this study. | Other | Physicians |
Primary outcome
Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on Physician Survey
Time frame: Up to 6 months
Physicians will be surveyed to assess the LDL-C levels at the time of a therapy decision.
Reductions in Low density Lipoprotein-Cholesterol (LDL-C) Levels Based on Physician Survey
Time frame: Up to 6 months
Physicians will be surveyed to determine their anticipated reductions in LDL-C levels as a result of therapy.
Visual Analogue Scale (VAS) Score Evaluating Relevance of Decision Factors and Considerations Relevant to Therapy Decision Based on Physician Survey
Time frame: Up to 6 months
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.
Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on a Retrospective Patient Chart Review
Time frame: Up to 6 months
A retrospective patient chart review will assess the LDL-C levels at the time of a therapy decision.
Number of Participants With Pre-specified Events in Their Medical History Based on a Retrospective Patient Chart Review
Time frame: Up to 6 months
A retrospective patient chart review will assess the number of participants with pre-specified events in their medical history.
Number of Participants With Specific Concomitant Diseases Based on a Retrospective Chart Review
Time frame: Up to 6 months
A retrospective patient chart review will assess the number of participants with specific concomitant diseases.
Number of Participants Implementing Specific Lifestyle Modifications Based on a Retrospective Patient Chart Review
Time frame: Up to 6 months
A retrospective patient chart review will assess the number of participants with specific lifestyle modifications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 63 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on Physician Survey (time frame: Up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.