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AzTrials

Primary HypercholesterolemiiaTRICONOSNCT06686615

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

An observational study of Primary Hypercholesterolemiia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 163 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 therapy to lower LDL-C. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bempedoic acid, Ezetimibe and Rosuvastatin
How many people
2,000 participants
Where
163 sitesin 5 countries
Study dates
12 Feb 2025to 31 Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Prospective data from routine clinical practice will be collected over the course of 1 year involving approximately 2000 patients across approximately 200 sites in Europe (Germany, Italy, Spain, Austria, and Belgium) treated by both specialized and non-specialized physicians in hospital and office-based settings.

Who may be able to join

  • 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,
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

163 sites in 5 countries.

163 sites in 5 countries

Italy43 sites

  • Ente Ecclesiastico "Miulli"

    Acquaviva delle Fonti, 70021

  • INRCA

    Ancona, 60127

  • AO Moscati

    Avellino, 83100

  • Osp. "San Paolo"

    Bari, 70123

  • Ospedale di Bolzano

    Bolzano, 39100

  • Spedali Civili di Brescia

    Brescia, 25123

  • Osp. santo spirito

    Casale Monferrato, 15033

  • Ospedale Sant'Anna e san Sebastiano

    Caserta, 81100

  • Policlinnico Mater Domini

    Catanzaro, 88100

  • Osp. SS Annunziata

    Chieti, 66100

  • PO Nuovo Umberti I

    Enna, 94100

  • Osp. Sant'Anna di Cona

    Ferrara, 44124

  • Policlinico "Riuniti"

    Foggia, 71122

  • Policlinico San Martino

    Genova, 16132

  • Osp della Misericordia

    Grosseto, 58100

  • Osp. "Vito Fazzi"

    Lecce, 73100

  • Ospedale Mater Salutis

    Legnagno, 37045

  • Spedali Riuniti

    Livorno, 57124

  • Ospedale di Mantova

    Mantua, 46100

  • Policlinico G. Martino

    Messina, 98124

  • IRCCS Monzino

    Milan, 20138

  • IRCCS Galeazzi Sant'Ambrogio

    Milan, 20157

  • Policlinico Modena

    Modena, 41125

  • AO Cardarelli

    Naples, 80131

  • Policlinico Federico II

    Naples, 80131

  • AOU Vanvitelli, I Policlinico

    Naples, 80138

  • Policlinico P. Giaccone

    Palermo, 90127

  • ICS Maugeri

    Pavi, 27100

  • S. Maria della Misericordia

    Perugia, 06129

  • Presidio Ospedaliero

    Pescara, 65124

  • Ospedale PederzoliItlit

    Peschiera, 37019

  • Cisanello

    Pisa, 56124

  • Osp. Santa Maria delle Croci

    Ravenna, 48121

  • Osp infermi di rivoli

    Rivoli, 10098

  • Policlinico Tor Vergata

    Roma, 00133

  • Ospedale Pertini

    Roma, 00157

  • Ospedale Sant'Andrea

    Roma, 00189

  • Policlinico Umberto I

    Rome, 00161

  • Molinette Università to

    Torino, 10126

  • Ospedale Mauriziano

    Torino, 10128

  • Osp. di Cattinara

    Trieste, 34149

  • Ospedale di Portogruaro

    Venezia, 30026

  • AOUI Verona

    Verona, 37126

Other trials in Italy

Germany38 sites

  • Praxis für Kardiologie Aachen

    Aachen, 52062

  • Klinikum Ahaus

    Ahaus, 48683

  • Praxis W. Almohamed

    Alsfed, 36304

  • Zentrum für klinische Studien Bad Homburg

    Bad Homburg, 61348

  • Dialysezentrum Hellersdorf Mitte

    Berlin, 12627

  • Lipidambulanz Charite Campus Virchow

    Berlin, 13353

  • MEDICLIN Reha-Zentrum Spreewald

    Burg, 03096

  • Kardiologische Gemeinschaftspraxis Flemmingstr.

    Chemnitz, 09116

  • Klinik Detmold

    Detmold, 32756

  • Praxis Dr. Methfessel

    Dresden, 01159

  • Cardiologicum Dresden

    Dresden, 01796

  • Herz- und Gefäßmedizin Goslar

    Goslar, 38640

  • ndgl.; viele Kombinationstherapien

    Gräfenhainichen, 06773

  • Praxis

    Greiz, 07973

  • Kardiologie am Tibarg

    Hamburg, 22459

  • Jessa Ziekenhuis

    Hasselt, 3500

  • HPK Heidelberger Praxisklinik

    Heidelberg, 69115

  • Uni-Klinik Heidelberg

    Heidelberg, 69120

  • Kardiopraxis

    Kaiserslautern, 67655

  • GK Mittelrhein

    Koblenz, 56073

  • Klinikum Konstanz

    Konstanz, 78464

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • DRK Krankenhaus Lichtenstein Gemeinnützige GmbH

    Lichtenstein, 09350

  • Cardio Centrum Ludwigsburg

    Ludwigsburg, 71634

  • Kardiopraxis

    Mainz, 55122

  • Kardiologische Praxis Markkleeberg

    Markkleeberg, 04416

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

    Moers, 47441

  • Praxis Dr. Norbert Schön

    Mühldorf A. Inn, 84453

  • Kardiologische Gemeinschaftpraxis Papenburg

    Papenburg, 26871

  • Kardiologische Gemeinschaftspraxis Papenburg

    Papenburg, 26871

  • Hausärztlich-kardiologisches MVZ,,Am Felsenkeller" GmbH

    Pirna, 01796

  • Kardiologische Gemeinschaftspraxis am Park Sanssouci

    Potsdam, 14469

  • Lipidambulanz Uniklinikum Regensburg

    Regensburg, 93053

  • Parkkardiologie, kard. Gemeinschaftspraxis

    Stanhsdorf B. Berlin, 14532

  • BBT Trier

    Trier, 54292

  • Diabetologische Schwerpunktpraxis

    Trier, 54292

  • Herzklinik

    Ulm, 89077

  • Dialysezentrum Hofaue

    Wuppertal, 42103

Other trials in Germany

Spain36 sites

  • H. Univers. De Albacete

    Albacete, 02006

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

  • H. General de Elche

    Alicante, 03203

  • Hospital Universitario de San Juan

    Alicante, 03550

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Hospital Universitario de Burgos

    Burgos, 09006

  • H. Univ. Puerta del Mar

    Cadiz, 11009

  • H. Punta de Europa

    Cadiz, 11207

  • Hospital Universitario Puerto Real

    Cadiz, 11510

  • Sierrallana Hospital

    Cantabria, 39300

  • H. Univ. Reina Sofía

    Córdoba, 14004

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014

  • H. Univ. De Cabueñes

    Gijón, 33394

  • H. Virgen de las Nieves

    Granada, 18014

  • H. Juan Ramón Jiménez

    Huelva, 21005

  • Hospital Universitario Médico-Quirúrgico de Jaén

    Jaén, 23007

  • Hospital Universitario de Gran Canarias Dr. Negrín

    Las Palmas de GC, 35010

  • Hospital de León

    León, 24008

  • Hospital San Pedro

    Logroño, 26006

  • H. Virgen de la Victoria

    Málaga, 29010

  • Hospital Serranía de Ronda

    Málaga, 29400

  • H. Costa del Sol

    Marbella (Málaga), 29603

  • Hospital General Universitario Reina Sofía

    Murcia, 30003

  • H. Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Son LLatzer

    Palma de Mallorca, 07198

  • Clínica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario de Navarra

    Pamplona, 31008

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital de Segovia

    Segovia, 40002

  • Hospital General Universitario de Toledo

    Toledo, 45007

  • H. Clínico Univ. De Valencia

    Valencia, 46010

  • Consorcio Hospital General Univ de Valencia

    Valencia, 46014

  • Hospital La Fe

    Valencia, 46026

  • Hospital Universitario de Álava

    Vitoria-Gasteiz, 01009

  • Hospital Clinico Universitaro Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Austria24 sites

  • Innere Medizin

    Braunau am Inn, 5280

  • Innere Medizin 1

    Feldkirch, 6800

  • Uniklinik Graz, Endokrinologie und Diabetes

    Graz, 8036

  • Uniklinik Graz, Kardiologie

    Graz, 8036

  • Innere Medizin 3 - Kardiologie

    Innsbruck, 6020

  • Klinikum Wels-Grieskirchen GmbH+B18

    Kepler Universitätsklinikum Gmb+, 4600

  • Innere Medizin

    Klagenfurt, 9020

  • Innere Medizin

    Linz, 4020

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

    Linz, 4021

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

    Linz, 4040

  • Ordination

    Mattersburg, 7210

  • Landesklinikum Mistelbach - Gänserndorf

    Mistelbach, 2130

  • Ordination Dr. med. univ. Evelyn Fließer-Görzer

    Saint Stefan Bei Graz, 8511

  • Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)

    Salzburg, 5020

  • DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen

    Salzburg, 5026

  • Klinik Landstrasse, Kardiologie

    Vienna, 1030

  • Ordination Univ.-Prof. Dr. Kurt Huber

    Vienna, 1060

  • Zentrum für Klinische Studien Dr. Hanusch GmbH

    Vienna, 1060

  • AKH Wien

    Vienna, 1090

  • Meduni Wien, Endokrinologie und Diabetes

    Vienna, 1090

  • Meduni Wien, Kardiologie

    Vienna, 1090

  • Clinic Hietzing

    Vienna, 1130

  • Herzzentrum 18

    Vienna, 1180

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

    Vienna, 1210

Other trials in Austria

Belgium22 sites

  • Azorg

    Aalst, 9300

  • UZA (Antwerp University Hospital)

    Antwerp, 2650

  • Epicure Hornu

    Boussu, 7301

  • A.Z. KLINA Brasschaat

    Brasschaat, 2930

  • Algemeen Ziekenhuis Sint-Jan Oostende

    Bruges, 8400

  • CHU Brugman

    Brussels, 1020

  • UZ Brussel

    Brussels, 1090

  • CHU Charleroi Hopital civil Marie-Curie

    Charleroi, 6042

  • GHDC Charleroi - Site Hôpital Saint-Joseph

    Charleroi, 6060

  • Z.O.L - Campus St. Jan

    Genk, 3600

  • Az Sint Lucas

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • CHR Huy

    Huy, 4500

  • AZ Groeninge Kortrijk

    Kortrijk, 8500

  • Pôle hospitalier Jolimont

    La Louvrière, 7100

  • JAN YPERMAN Ziekenhuis

    Leper, 8900

  • UZ Leuven

    Leuven, 3000

  • CHR Citadelle de Liège

    Liège, 4000

  • CHU Mons Ambroise Paré

    Mons, 7000

  • AZ Delta

    Roeselare, 8800

  • AZ Glorieux

    Ronse, 9600

  • CHU UCL Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

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.

Read the 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 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
Being tested
Bempedoic acid, Ezetimibe, Rosuvastatin, Atorvastatin
Keywords
Primary hypercholesterolemia, Mixed dyslipidemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bempedoic acidDrug

    No drug was administered in this observational study.

  • EzetimibeDrug

    No drug was administered in this observational study.

  • RosuvastatinDrug

    No drug was administered in this observational study.

  • AtorvastatinDrug

    No drug was administered in this observational study.

Study groups in NCT06686615
Study groupRoleWhat they receive
Triple therapyAdult 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.
Receives: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Rosuvastatin; Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative LDL-C change between untreated and 8 week after triple therapy start

    LDL-C will be assessed using a standard lipid panel blood test,

    Measured: Baseline to 8 weeks after initiation of triple therapy

Secondary outcomes (8)

  1. Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year

    The 2019 EAS/ESC guidelines recommend treatment targets of at least a 50% reduction from baseline LDL-C levels and an LDL-C concentration below 1.8 mmol/L for patients at high and 1.4 mmol/l for patients at very high cardiovascular risk.

    Measured: Baseline to 1 year after initiation of triple therapy

  2. Relative LDL-C change between untreated and 1 year after triple therapy start

    LDL-C will be assessed using a standard lipid panel blood test,

    Measured: From any prior LMT exposure to 1 year after initiation of triple therapy

  3. Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 8 weeks after triple therapy start

    LDL-C will be assessed using a standard lipid panel blood test,

    Measured: From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy

  4. Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 1 year after triple therapy start

    LDL-C will be assessed using a standard lipid panel blood test,

    Measured: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy

  5. Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter

    Labs will be assessed using a standard panel blood test,

    Measured: Baseline to 1 year after initiation of triple therapy

  6. Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start

    Adherence will be judged by the physician/patient.

    Measured: Baseline to 1 year after initiation of triple therapy

  7. Incidence of adverse events under triple therapy exposure

    Adverse events are defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Baseline to 1 year after initiation of triple therapy

  8. Proportion of patients with MACE-3 and MACE-4 events

    MACE-3 and MACE-4 events will consist of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only).

    Measured: Baseline to 1 year after initiation of triple therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start12 Feb 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

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
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686615
Sponsor's protocol ID
DSE-BMP-01-24-EU
Acronym
TRICONOS
Status last verified
Sep 2026
First submitted
11 Nov 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hypercholesterolemiia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 163 sites in 5 countries.

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 10 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Italy, Germany, Spain, Austria, Belgium. 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?

This study is still under way. Results are not available in the source record yet.

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?

Relative LDL-C change between untreated and 8 week after triple therapy start (time frame: Baseline to 8 weeks after initiation of triple therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06686615.

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 30 Sep 2026.

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