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

NCT ID: NCT06686615

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-12

Study Completion Date

2028-01-31

Brief Summary

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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 therapy to lower LDL-C.

Detailed Description

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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 real-world clinical setting. No drug will be administered during this observational study.

The primary objective of the study is to evaluate the effectiveness of the triple therapy in terms of LDL-C reduction at 8 weeks.

The secondary objectives will include the following:

* Goal attainment at 8 weeks and 1 year after start of triple therapy
* Effectiveness of triple therapy in terms of LDL-C reduction at 1 year
* Effectiveness of adding bempedoic acid to statin and ezetimbe at 8 weeks and 1 year
* Effectiveness of adding bempedoic acid/ezetimibe FDC to statin in terms of LDL-C reduction at 8 weeks and 1 year
* Changes in laboratory values at 8 weeks and 1 year after start of triple therapy
* Adherence to triple therapy treatment
* Collection and recording of all adverse events occurred since initiation of triple therapy
* MACE-3 and MACE-4 (consisting of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only)) during the year of follow-up
* Treatment changes at LMT initiation and at triple therapy initiation
* Treatment pathway from triple therapy initiation to 1-year after start of triple therapy

Conditions

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Primary Hypercholesterolemiia Mixed Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Triple therapy

Adult patients who have been diagnosed with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia treated with bempedoic acid in combination with ezetimibe and either rosuvastatin or atorvastatin (ie, triple therapy) and will be followed for up to 1 year after initiation of triple therapy.

A direct comparison between rosuvastatin and atorvastatin is not planned, only an assessment of triple therapy on LDL-C change in patients with primary hypercholesterolaemia.

Bempedoic acid

Intervention Type DRUG

No drug was administered in this observational study.

Ezetimibe

Intervention Type DRUG

No drug was administered in this observational study.

Rosuvastatin

Intervention Type DRUG

No drug was administered in this observational study.

Atorvastatin

Intervention Type DRUG

No drug was administered in this observational study.

Interventions

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Bempedoic acid

No drug was administered in this observational study.

Intervention Type DRUG

Ezetimibe

No drug was administered in this observational study.

Intervention Type DRUG

Rosuvastatin

No drug was administered in this observational study.

Intervention Type DRUG

Atorvastatin

No drug was administered in this observational study.

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Innere Medizin

Braunau am Inn, , Austria

Site Status RECRUITING

Innere Medizin 1

Feldkirch, , Austria

Site Status ACTIVE_NOT_RECRUITING

Klinikum Wels-Grieskirchen GmbH+B18

Kepler Universitätsklinikum Gmb+, , Austria

Site Status ACTIVE_NOT_RECRUITING

Innere Medizin

Klagenfurt, , Austria

Site Status ACTIVE_NOT_RECRUITING

Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin

Linz, , Austria

Site Status ACTIVE_NOT_RECRUITING

Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr

Linz, , Austria

Site Status RECRUITING

Ordination

Mattersburg, , Austria

Site Status RECRUITING

Ordination Dr. med. univ. Evelyn Fließer-Görzer

Saint Stefan Bei Graz, , Austria

Site Status RECRUITING

Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)

Salzburg, , Austria

Site Status RECRUITING

DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen

Salzburg, , Austria

Site Status RECRUITING

Ordination Univ.-Prof. Dr. Kurt Huber

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

Zentrum für Klinische Studien Dr. Hanusch GmbH

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

AKH Wien

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

Meduni Wien, Kardiologie

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

Clinic Hietzing

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

Herzzentrum 18

Vienna, , Austria

Site Status RECRUITING

Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

Azorg

Aalst, , Belgium

Site Status RECRUITING

A.Z. KLINA Brasschaat

Brasschaat, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Algemeen Ziekenhuis Sint-Jan Oostende

Bruges, , Belgium

Site Status RECRUITING

Z.O.L - Campus St. Jan

Genk, , Belgium

Site Status RECRUITING

AZ Groeninge Kortrijk

Kortrijk, , Belgium

Site Status ACTIVE_NOT_RECRUITING

JAN YPERMAN Ziekenhuis

Leper, , Belgium

Site Status ACTIVE_NOT_RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

AZ Glorieux

Ronse, , Belgium

Site Status RECRUITING

Praxis für Kardiologie Aachen

Aachen, , Germany

Site Status RECRUITING

Klinikum Ahaus

Ahaus, , Germany

Site Status ACTIVE_NOT_RECRUITING

Zentrum für klinische Studien Bad Homburg

Bad Homburg, , Germany

Site Status RECRUITING

MEDICLIN Reha-Zentrum Spreewald

Burg, , Germany

Site Status RECRUITING

Kardiologische Gemeinschaftspraxis Flemmingstr.

Chemnitz, , Germany

Site Status RECRUITING

Praxis Dr. Methfessel

Dresden, , Germany

Site Status RECRUITING

Cardiologicum Dresden

Dresden, , Germany

Site Status RECRUITING

Herz- und Gefäßmedizin Goslar

Goslar, , Germany

Site Status ACTIVE_NOT_RECRUITING

ndgl.; viele Kombinationstherapien

Gräfenhainichen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Praxis

Greiz, , Germany

Site Status RECRUITING

Kardiologie am Tibarg

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Kardiopraxis

Kaiserslautern, , Germany

Site Status RECRUITING

GK Mittelrhein

Koblenz, , Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum Konstanz

Konstanz, , Germany

Site Status RECRUITING

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Cardio Centrum Ludwigsburg

Ludwigsburg, , Germany

Site Status RECRUITING

Kardiologische Praxis Markkleeberg

Markkleeberg, , Germany

Site Status RECRUITING

Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking

Moers, , Germany

Site Status RECRUITING

Praxis Dr. Norbert Schön

Mühldorf A. Inn, , Germany

Site Status RECRUITING

Kardiologische Gemeinschaftpraxis Papenburg

Papenburg, , Germany

Site Status RECRUITING

Kardiologische Gemeinschaftspraxis Papenburg

Papenburg, , Germany

Site Status RECRUITING

Hausärztlich-kardiologisches MVZ,,Am Felsenkeller" GmbH

Pirna, , Germany

Site Status RECRUITING

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, , Germany

Site Status RECRUITING

Parkkardiologie, kard. Gemeinschaftspraxis

Stanhsdorf B. Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Diabetologische Schwerpunktpraxis

Trier, , Germany

Site Status RECRUITING

Herzklinik

Ulm, , Germany

Site Status RECRUITING

Dialysezentrum Hofaue

Wuppertal, , Germany

Site Status ACTIVE_NOT_RECRUITING

INRCA

Ancona, , Italy

Site Status RECRUITING

Osp. "San Paolo"

Bari, , Italy

Site Status RECRUITING

Ospedale di Bolzano

Bolzano, , Italy

Site Status RECRUITING

Spedali Civili di Brescia

Brescia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale Sant'Anna e san Sebastiano

Caserta, , Italy

Site Status RECRUITING

Osp. SS Annunziata

Chieti, , Italy

Site Status RECRUITING

Osp. Sant'Anna di Cona

Ferrara, , Italy

Site Status ACTIVE_NOT_RECRUITING

Policlinico "Riuniti"

Foggia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Policlinico San Martino

Genova, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale di Mantova

Mantova, , Italy

Site Status RECRUITING

IRCCS Galeazzi Sant'Ambrogio

Milan, , Italy

Site Status ACTIVE_NOT_RECRUITING

Policlinico Federico II

Napoli, , Italy

Site Status RECRUITING

Policlinico P. Giaccone

Palermo, , Italy

Site Status RECRUITING

Ospedale PederzoliItlit

Peschiera, , Italy

Site Status ACTIVE_NOT_RECRUITING

Osp infermi di rivoli

Rivoli, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale Sant'Andrea

Roma, , Italy

Site Status RECRUITING

Policlinico Umberto I

Rome, , Italy

Site Status RECRUITING

Ospedale Mauriziano

Torino, , Italy

Site Status ACTIVE_NOT_RECRUITING

Osp. di Cattinara

Trieste, , Italy

Site Status ACTIVE_NOT_RECRUITING

H. Univers. De Albacete

Albacete, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, , Spain

Site Status ACTIVE_NOT_RECRUITING

H. General de Elche

Alicante, , Spain

Site Status RECRUITING

Hospital Universitario de San Juan

Alicante, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario de Burgos

Burgos, , Spain

Site Status ACTIVE_NOT_RECRUITING

H. Univ. Puerta del Mar

Cadiz, , Spain

Site Status ACTIVE_NOT_RECRUITING

H. Punta de Europa

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Puerto Real

Cadiz, , Spain

Site Status ACTIVE_NOT_RECRUITING

Sierrallana Hospital

Cantabria, , Spain

Site Status ACTIVE_NOT_RECRUITING

H. Univ. Reina Sofía

Córdoba, , Spain

Site Status ACTIVE_NOT_RECRUITING

H. Univ. De Cabueñes

Gijón, , Spain

Site Status ACTIVE_NOT_RECRUITING

H. Virgen de las Nieves

Granada, , Spain

Site Status RECRUITING

H. Juan Ramón Jiménez

Huelva, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario Médico-Quirúrgico de Jaén

Jaén, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario de Gran Canarias Dr. Negrín

Las Palmas de GC, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital de León

León, , Spain

Site Status RECRUITING

H. Costa del Sol

Marbella (Málaga), , Spain

Site Status RECRUITING

H. Virgen de la Victoria

Málaga, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Serranía de Ronda

Málaga, , Spain

Site Status RECRUITING

H. Virgen de la Arrixaca

Murcia, , Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status RECRUITING

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital de Segovia

Segovia, , Spain

Site Status RECRUITING

Hospital La Fe

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario de Álava

Vitoria-Gasteiz, , Spain

Site Status RECRUITING

Hospital Clinico Universitaro Lozano Blesa

Zaragoza, , Spain

Site Status ACTIVE_NOT_RECRUITING

Countries

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Austria Belgium Germany Italy Spain

Central Contacts

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Daiichi Sankyo Contact for Clinical Trial Information

Role: CONTACT

[email protected]
9089926400

Facility Contacts

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Other Identifiers

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DSE-BMP-01-24-EU

Identifier Type: -

Identifier Source: org_study_id