Bempedoic acid for Coronary artery disease | Myocardial infarction | ST-elevation myocardial infarction | Non-ST-elevation myocardial infarction

Inclusion criteria

• {"criterion_text":"- Men, women, inter/diverse* aged ≥ 18 and ≤ 85 years"}
• {"criterion_text":"- Signed written informed consent"}
• {"criterion_text":"- NSTEMI or STEMI with successful PCI within 7 days prior to screening"}
• {"criterion_text":"- Therapy naïve LDL-C > 100 mg/ dl"}
• {"criterion_text":"- Ensured compliance: patient should be able to cooperate with protocol regimen and follow-up"}
• {"criterion_text":"- *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

• {"criterion_text":"- History of gout"}
• {"criterion_text":"- Scheduled surgery within the next 4 months"}
• {"criterion_text":"- Patients who cannot come to revisits"}
• {"criterion_text":"- Participation in another clinical trial within 30 days before study start or during the trial"}
• {"criterion_text":"- Hypersensitivity to any of the components of the medications used"}
• {"criterion_text":"- Pregnancy / Breast-feeding"}
• {"criterion_text":"- Patients with severe renal disorders (defined as eGFR <30 ml/min/1,73 m2 ) or patients requiring dialysis with endstage renal disease"}
• {"criterion_text":"- Patients with history of tendon disorders or tendon rupture"}
• {"criterion_text":"- Person who is placed in an mental institution by court or official order"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Proportion (%) of patients achieving ESC LDL-C target defined as LDL-C < 55 mg/dl measured after 8 weeks of triple therapy in the specified patient group (patients who did not reach target after 6 weeks of dual therapy)."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion (%) achieving LDL-C < 55 mg/dl measured at weeks 6 and 14 during dual therapy."}
• {"endpoint_text":"- Proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets after 14 weeks of treatment.","definition_or_measurement_approach":"Proportion (%) achieving ESC LDL-C target (LDL-C < 55 mg/dl) measured at week 14."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion (%) achieving LDL-C < 70 mg/dl measured at week 14 in the triple therapy group."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Mean change from baseline to weeks 6 and 14 for listed laboratory and vital sign measures."}
• {"endpoint_text":"- Proportion of non-compliant patients (%) taking less than 90% of the allocated study medication","definition_or_measurement_approach":"Proportion (%) of patients with medication adherence <90% of allocated study medication."}
• {"endpoint_text":"- Mean change from baseline to week 6 and to week 14 in Quality of Life","definition_or_measurement_approach":"Mean change from baseline to weeks 6 and 14 in Quality of Life (instrument not specified)."}

Germany

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

08-11-2024

Processing Time Days

121

Number Of Sites

1

Number Of Participants

135

Primary sponsor

Full Name

Medizinische Hochschule Hannover

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"sponsorDuties codes: [8]","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"sponsorDuties codes: [1, 12, 6]","organisation_type":"Educational Institution"}