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:
-
Written informed consent to participate
-
At least 18 years of age
-
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
-
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:
- Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
- 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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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