Status:

RECRUITING

A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Lead Sponsor:

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Conditions:

Primary Hypercholesterolemiia

Mixed Dyslipidemia

Eligibility:

All Genders

18+ years

Brief Summary

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination th...

Detailed Description

The aim of the current study is to evaluate the effectiveness and safety of bempedoic acid combined with ezetimibe and either atorvastatin or rosuvastatin (hereafter defined as triple therapy) in a re...

Eligibility Criteria

Key Inclusion Criteria:

  1. Written informed consent to participate

  2. At least 18 years of age

  3. High and very high risk patients as assessed by the physician suffering from documented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment

  4. Patients treated with:

    • bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,
    • bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,
    • bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe
    • initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatin simultaneously

6) Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.

8) No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy > 1 -year

Key Exclusion Criteria:

  1. Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
  2. Patients who have ever received PCSK9i-siRNA treatment

Key Trial Info

Start Date :

February 12 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2028

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT06686615

Start Date

February 12 2025

End Date

January 31 2028

Last Update

April 7 2026

Active Locations (163)

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Page 1 of 41 (163 locations)

1

Innere Medizin

Braunau am Inn, Austria, 5280

2

Innere Medizin 1

Feldkirch, Austria, 6800

3

Uniklinik Graz, Endokrinologie und Diabetes

Graz, Austria, 8036

4

Uniklinik Graz, Kardiologie

Graz, Austria, 8036