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

Daiichi Sankyo

Status: Enrolling

Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemiia

Treatments: Drug: Bempedoic acid; Drug: Atorvastatin; Drug: Ezetimibe; Drug: Rosuvastatin

Study type: Observational

Funder types: Industry

Identifiers

NCT06686615

DSE-BMP-01-24-EU

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

7. 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

Trial design

2,000 participants in 1 patient group

Triple therapy

Description:

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.

Treatment:

Drug: Rosuvastatin

Drug: Ezetimibe

Drug: Atorvastatin

Drug: Bempedoic acid