Clinical study to evaluate the effectiveness of the active ingredient Bempedoic acid in patients following myocardial infarctions insufficiently treated with the drugs atorvastatin plus ezetimibe.

A prospective, interventional, single-center, single-arm study to assess the effectiveness of Bempedoic acid to achieve LDL-cholesterol targets in patients following ST-elevation or Non-ST-elevation myocardial infarctions insufficiently treated with atorvastatin plus ezetimibe

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003526-50-DE

Enrollment

135

Registered

2023-01-27

Start date

2023-05-09

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients following acute percutaneous coronary intervention for STEMI or NSTEMI insufficiently treated with high-intensity oral lipid lowering therapy MedDRA version: 20.0 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Nilemdo® Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bempedoic acid CAS Number: 738606-46-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men, women, inter/diverse* aged = 18 and = 85 years 2. Signed written informed consent 3. NSTEMI or STEMI with successful PCI within 7 days prior to screening 4. Therapy naïve LDL-C > 100 mg/dl 5. Ensured compliance: patient should be able to cooperate with protocol regimen and follow-up 6. *Patients without childbearing potential defined as follows: • at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or • hysterectomy or uterine agenesis or • = 50 years and in postmenopausal state for > 1 year or • 1 year with serum FSH > 40 IU/l and serum estrogen =65 years) yes F.1.3.1 Number of subjects for this age range 68

Exclusion criteria

Exclusion criteria: 1. History of gout 2. Scheduled surgery within the next 4 months 3. Patients who cannot come to revisits 4. Participation in another clinical trial within 30 days before study start or during the trial 5. Hypersensitivity to any of the components of the medications used 6. Pregnancy / Breast-feeding 7. Patients with severe renal disorders (defined as eGFR <30 ml/min/1,73 m2) or patients requiring dialysis with endstage renal disease 8. Patients with history of tendon disorders or tendon rupture 9. Person who is placed in an mental institution by court or official order

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets (LDL-C < 55 mg/dl) after 8 weeks of treatment with the triple therapy of atorvastatin plus ezetimibe and additive bempedoic acid (180 mg/d) in a group of patients that did not reach the ESC LDL-C guideline targets after 6 weeks of treatment with dual therapy including atorvastatin (at least 40 mg/d or equivalent) plus ezetimibe (10 mg/d).;Secondary Objective: 1) To determine the proportion of patients (%) who successfully achieve ESC LDL-C guideline targets (LDL-C < 55 mg/dl) after treatment with dual therapy including atorvastatin (at least 40 mg/d or equivalent) plus ezetimibe (10 mg/d) for 6 and 14weeks 2) To determine the proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets after 14 weeks of treatment 3) To determine the proportion of patients (%) who achieve AHA/ACC guideline recommended treatment targets of LDL-C < 70 mg/dl after 14 weeks of treatment in the triple therapy group 4) To examine the change in lipid levels during the study 5) To examine the adherence to medication by the proportion of non-compliant patients (%) taking less than 90% of the allocated study medication 6) To examine the change in Quality of Life Assessment of safety: Safety assessments will consist of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs) and safety lab. ;Primary end point(s): Proportion of patients (%) in group A who successfully achieve the ESC LDL-C guideline targets after stage II defined as the proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets (LDL-C < 55 mg/dl) following 8 weeks of treatment with the triple therapy of atorvastatin plus ezetimibe and additive bempedoic acid (180 mg/d) in the group of patients that did not reach the LDL-C guideline targets after 6 weeks of treatment with dual therapy including atorvastatin (at least 40 mg/d or equival	—

Measure

Time frame

Main Objective: To determine the proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets (LDL-C < 55 mg/dl) after 8 weeks of treatment with the triple therapy of atorvastatin plus ezetimibe and additive bempedoic acid (180 mg/d) in a group of patients that did not reach the ESC LDL-C guideline targets after 6 weeks of treatment with dual therapy including atorvastatin (at least 40 mg/d or equivalent) plus ezetimibe (10 mg/d).;Secondary Objective: 1) To determine the proportion of patients (%) who successfully achieve ESC LDL-C guideline targets (LDL-C < 55 mg/dl) after treatment with dual therapy including atorvastatin (at least 40 mg/d or equivalent) plus ezetimibe (10 mg/d) for 6 and 14weeks 2) To determine the proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets after 14 weeks of treatment 3) To determine the proportion of patients (%) who achieve AHA/ACC guideline recommended treatment targets of LDL-C < 70 mg/dl after 14 weeks of treatment in the triple therapy group 4) To examine the change in lipid levels during the study 5) To examine the adherence to medication by the proportion of non-compliant patients (%) taking less than 90% of the allocated study medication 6) To examine the change in Quality of Life Assessment of safety: Safety assessments will consist of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs) and safety lab. ;Primary end point(s): Proportion of patients (%) in group A who successfully achieve the ESC LDL-C guideline targets after stage II defined as the proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets (LDL-C < 55 mg/dl) following 8 weeks of treatment with the triple therapy of atorvastatin plus ezetimibe and additive bempedoic acid (180 mg/d) in the group of patients that did not reach the LDL-C guideline targets after 6 weeks of treatment with dual therapy including atorvastatin (at least 40 mg/d or equival

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Proportion of patients (%) who successfully achieve ESC LDL-C guideline targets (LDL-C < 55 mg/dl) after treatment with dual therapy including atorvastatin (at least 40 mg/d or equivalent) plus ezetimibe (10 mg/d) for 6 and for 14 weeks 2) Proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets after 14 weeks of treatment. 3) Proportion of patients (%) who achieve AHA/ACC guideline recommended treatment targets of LDL-C < 70 mg/dl after 14 weeks of treatment in the triple therapy group 4) Mean change from baseline to week 6 and to week 14 in LDL-C, total cholesterol, HDL-C, triglycerides, uric acid, creatine kinase, systolic and diastolic blood pressure, pulse 5) Proportion of non-compliant patients (%) taking less than 90% of the allocated study medication 6) Mean change from baseline to week 6 and to week 14 in Quality of Life 7) Monitoring and recording of all AEs and SAEs (triple therapy group and double therapy group from dispense of IMP onwards (V2)), safety lab;Timepoint(s) of evaluation of this end point: 1) from baseline to week 6 and week 14 2) after 14 weeks of treatment 3) after 14 weeks of treatment in the triple therapy group 4) from baseline to week 6 and to week 14 5) from start of treatment until EOT 6) from baseline to week 6 and week 14 7) from start of treatment (V2) until FU	—

Measure

Time frame

Secondary end point(s): 1) Proportion of patients (%) who successfully achieve ESC LDL-C guideline targets (LDL-C < 55 mg/dl) after treatment with dual therapy including atorvastatin (at least 40 mg/d or equivalent) plus ezetimibe (10 mg/d) for 6 and for 14 weeks 2) Proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets after 14 weeks of treatment. 3) Proportion of patients (%) who achieve AHA/ACC guideline recommended treatment targets of LDL-C < 70 mg/dl after 14 weeks of treatment in the triple therapy group 4) Mean change from baseline to week 6 and to week 14 in LDL-C, total cholesterol, HDL-C, triglycerides, uric acid, creatine kinase, systolic and diastolic blood pressure, pulse 5) Proportion of non-compliant patients (%) taking less than 90% of the allocated study medication 6) Mean change from baseline to week 6 and to week 14 in Quality of Life 7) Monitoring and recording of all AEs and SAEs (triple therapy group and double therapy group from dispense of IMP onwards (V2)), safety lab;Timepoint(s) of evaluation of this end point: 1) from baseline to week 6 and week 14 2) after 14 weeks of treatment 3) after 14 weeks of treatment in the triple therapy group 4) from baseline to week 6 and to week 14 5) from start of treatment until EOT 6) from baseline to week 6 and week 14 7) from start of treatment (V2) until FU

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Countries

Germany

Contacts

Public ContactDepart. of Cardiology and Angiology

Hannover Medical School

kardiologie@mh-hannover.de+495115326054

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Jun 5, 2026