Health Trials

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

ConditionsPrimary HypercholesterolemiiaMixed Dyslipidemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bempedoic acid

    Drug

    No drug was administered in this observational study.

  • Ezetimibe

    Drug

    No drug was administered in this observational study.

  • Rosuvastatin

    Drug

    No drug was administered in this observational study.

  • Atorvastatin

    Drug

    No drug was administered in this observational study.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Triple therapy4 interventions

Trial outcomes

Primary outcomes

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,

Time frame
Baseline to 8 weeks after initiation of triple therapy

Secondary outcomes

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.

Time frame
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,

Time frame
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,

Time frame
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,

Time frame
From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Lead sponsor

Source ClinicalTrials.gov
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