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Completed

NCT Number: 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®

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kardiologische Gemeinschaftspraxis (Bulut), Arnsberg, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab

Drug

No study drug was administered during this study.

Other names: NUSTENDI®

No study drug

Other

No study drug was administered during this study.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Industry

Collaborators

  • Daiichi Sankyo Germany

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2022
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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