Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome (CLEAR ACS) Study
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
研究概览
简要总结
The overall objective of the Cholesterol Lowering via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome ACS (CLEAR ACS) study is to determine the efficacy, safety, and tolerability of bempedoic acid/ezetimibe (BA/E) in a contemporary and real-world population, enriched for older adults, women, and underrepresented racial/ethnic groups, of adults with a recent acute coronary syndrome (ACS) event independent of use of statin therapy before the ACS event.
详细描述
The CLEAR ACS study is a prospective, virtual, electronic health record (EHR)-based, randomized, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial (PCT) embedded within Kaiser Permanente Northern California's fully integrated and learning health care delivery system. The EHR will be screened in real-time for potentially eligible participants across all Kaiser Permanente Northern California hospitals using validated diagnostic and procedural codes, disease registries, laboratory values, pharmacy dispensing information, and sociodemographic data sources. Eligible patients that provide informed consent will be randomized in a 1:1 allocation ratio to an initial 12 weeks of blinded bempedoic acid/ezetimibe (BA/E) vs. matching placebo followed by a 12-week open-label extension phase where all patients will receive open-label, unblinded bempedoic acid/ezetimibe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age >18 years
- •Able to provide informed consent
- •A documented recent ACS event (i.e., defined as up to 14 days post-discharge from an index hospitalization for a non-ST-elevation MI [NSTEMI] or ST-elevation MI [STEMI] necessitating urgent and/or emergent percutaneous coronary intervention [PCI] and/or coronary after bypass graft [CABG])
- •At least 6 months of continuous health plan membership and prescription drug benefit prior to enrollment
- •A registered e-mail address with Kaiser Permanente in order to obtain electronic consent (eConsent) for study participation
排除标准
- •Receipt of BA/E on or within 3 months before the day of enrollment
- •A history of hypersensitivity to BA/E
- •Women who are pregnant or planning to become pregnant and/or breastfeeding mothers
- •A diagnosis of gout and/or previously known laboratory-confirmed hyperuricemia (serum uric acid >8.0 mg/dL)
- •A history of tendon disorders or tendon rupture
- •Current and/or planned treatment with simvastatin/pravastatin, cyclosporine, fibrates, and/or bile acid sequestrants (to avoid drug-drug interactions)
- •A known life-limiting diagnosis (e.g., stage D heart failure, severe liver disease, end-stage kidney disease [ESKD] requiring chronic dialysis or an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, metastatic cancer and/or actively receiving systemic chemotherapy)
- •Institutionalized and/or receiving palliative care
- •Non-English speaking
研究组 & 干预措施
Intervention
Bempedoic acid 180 mg/ezetimibe 10 mg
干预措施: Bempedoic Acid / Ezetimibe Oral Tablet (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
时间窗: 0-12 weeks
Percent (%) change from baseline to week 12 in LDL-C level
次要结局
- To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.(0-12 weeks)