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Summary
EudraCT Number:2022-003526-50
Sponsor's Protocol Code Number:HACOL-ACS
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2023-01-27
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2022-003526-50
A.3Full title of the trial
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
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
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.4.1Sponsor's protocol code numberHACOL-ACS
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorHannover Medical School
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support Daiichi-Sankyo Germany GmbH
B.4.2CountryGermany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationHannover Medical School
B.5.2Functional name of contact pointDepart. of Cardiology and Angiology
B.5.3 Address:
B.5.3.1Street AddressCarl-Neuberg-Str. 1
B.5.3.2Town/ cityHannover
B.5.3.3Post code30625
B.5.3.4CountryGermany
B.5.4Telephone number+495115326054
B.5.5Fax number+495115323507
B.5.6E-mailkardiologie@mh-hannover.de
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Nilemdo®
D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNBempedoic acid
D.3.9.1CAS number 738606-46-7
D.3.9.4EV Substance CodeSUB183128
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number180
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Patients following acute percutaneous coronary intervention for STEMI or NSTEMI insufficiently treated with high-intensity oral lipid lowering therapy
E.1.1.1Medical condition in easily understood language
patients following myocardial infarctions insufficiently treated with high-intensity oral lipid lowering therapy
E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10064345
E.1.2Term ST segment elevation myocardial infarction
E.1.2System Organ Class 10007541 - Cardiac disorders
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10064347
E.1.2Term Non ST segment elevation myocardial infarction
E.1.2System Organ Class 10007541 - Cardiac disorders
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
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).
E.2.2Secondary objectives of the trial
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.
E.2.3Trial contains a sub-study No
E.3Principal 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
•< 50 years and in postmenopausal state for > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
or
*Patients of childbearing potential:
•who are practising sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
•who have same sexual relationships only and/or have sexual relationships with sterile partners or
•who are sexually active with fertile partner, have a negative pregnancy test dur-ing screening and agree to use reliable methods of contraception** from the time of screening until end of the clinical trial and for a period of 4 days following the last administration of study medication.
**The following methods of contraception are acceptable (failure rate of < 1% per year/highly effective):
-combined (estrogen and progesterone containing) hormonal contraception (oral/intravaginal/transdermal) associated with inhibition of ovulation,
-progestogen-only hormonal contraception (oral, injectable, implantable) as-sociated with inhibition of ovulation,
-intrauterine device (IUD),
-intrauterine hormone-releasing system (IUS)
E.4Principal 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
E.5 End points
E.5.1Primary 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 equivalent) plus ezetimibe (10 mg/d).
E.5.1.1Timepoint(s) of evaluation of this end point
following 8 weeks of treatment with the triple therapy of atorvastatin plus ezetimibe and additive bempedoic acid (180 mg/d)
E.5.2Secondary 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
E.5.2.1Timepoint(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
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.2.4Number of treatment arms in the trial1
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months22
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 67
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 68
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state135
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2023-05-09
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-04-28
P. End of Trial
P.End of Trial StatusOngoing

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