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HAnnover ChOlesterol Lowering study in ACS
EU CTIS ID: 2024-513703-13-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History of gout
- Scheduled surgery within the next 4 months
- Patients who cannot come to revisits
- Participation in another clinical trial within 30 days before study start or during the trial
- Hypersensitivity to any of the components of the medications used
- Pregnancy / Breast-feeding
See the full eligibility criteria
- 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
- History of gout
- Scheduled surgery within the next 4 months
- Patients who cannot come to revisits
- Participation in another clinical trial within 30 days before study start or during the trial
- Hypersensitivity to any of the components of the medications used
- Pregnancy / Breast-feeding
- Patients with severe renal disorders (defined as eGFR <30 ml/min/1,73 m2 ) or patients requiring dialysis with endstage renal disease
- Patients with history of tendon disorders or tendon rupture
- Person who is placed in an mental institution by court or official order
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.