HAnnover ChOlesterol Lowering study in ACS
Key facts
- Where
- Hanover, NémetországSee the site
- Phase
- 3. fázis
Where in Németország
- Medizinische Hochschule HannoverHanover, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medizinische Hochschule Hannover
- Trial code
- EU 2024-513703-13-00
- Record updated
- 2025. február 11.
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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.
Exclusion: Scheduled surgery within the next 4 months; Participation in another clinical trial within 30 days before study start or during the trial; History of gout; Hypersensitivity to any of the components of the medications used; Patients with history of tendon disorders or tendon rupture; Patients with severe renal disorders (defined as eGFR <30 ml/min/1,73 m2 ) or patients requiring dialysis with endstage renal disease; Patients who cannot come to revisits; Pregnancy / Breast-feeding; Person who is placed in an mental institution by court or official order.