2024-513703-13-00CompletedPhase 3
HAnnover ChOlesterol Lowering study in ACS
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 (HACOL-ACS)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 135 (actual)
- First submitted
- 15 Oct 2024
- Start date
- 30 Jun 2023
- Lead sponsor
- Medizinische Hochschule Hannover
- Diseases
- Coronary artery disease
- EU CT number
- 2024-513703-13-00
- EudraCT number
- 2022-003526-50
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 135
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled surgery within the next 4 months
- Participation in another clinical trial within 30 days before study start or during the trial
Other illness
- History of gout
- Hypersensitivity to any of the components of the medications used
- Patients with history of tendon disorders or tendon rupture
Lab values
- Patients with severe renal disorders (defined as eGFR <30 ml/min/1,73 m2 ) or patients requiring dialysis with endstage renal disease
Other
- Patients who cannot come to revisits
- Pregnancy / Breast-feeding
- Person who is placed in an mental institution by court or official order
Who the study is looking for
- Men, women, inter/diverse* aged ≥ 18 and ≤ 85 years
- Signed written informed consent
- NSTEMI or STEMI with successful PCI within 7 days prior to screening
- Therapy naïve LDL-C > 100 mg/ dl
- Ensured compliance: patient should be able to cooperate with protocol regimen and follow-up
- *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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.