HAnnover ChOlesterol Lowering study in ACS

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medizinische Hochschule Hannover

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

30 Jun 2023 → ongoing

Decision date (initial)

2024-11-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Daiichi-Sankyo

External identifiers

EU CT number

2024-513703-13-00

EudraCT number

2022-003526-50

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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 objectives 6

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 14 weeks
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

Conditions and MedDRA coding

Coronary artery disease/myocardial infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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 during 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

Exclusion criteria 9

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients (%) in group A 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).

Secondary endpoints 6

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medizinische Hochschule Hannover

Sponsor organisation

Medizinische Hochschule Hannover

Address

Carl-Neuberg-Strasse 1, Gross Buchholz Gross Buchholz

City

Hanover

Postcode

30625

Country

Germany

Scientific contact point

Organisation

Medizinische Hochschule Hannover

Contact name

Kardiologie Studienambulanz

Public contact point

Organisation

Medizinische Hochschule Hannover

Contact name

Kardiologie Studienambulanz

Third parties 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications