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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
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).
次要结局
- Proportion of patients (%) who successfully achieve the ESC LDL-C guideline targets after 14 weeks of treatment.
- 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
- 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
- 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
- Proportion of non-compliant patients (%) taking less than 90% of the allocated study medication
- Mean change from baseline to week 6 and to week 14 in Quality of Life
研究者
Kardiologie Studienambulanz
Scientific
Medizinische Hochschule Hannover