2025-524625-41-00招募中3 期
Effects of bempedoic acid/ezetimibe/high-intensity statin on plaque regression and stabilisation of coronary atherosclerosis among patients without cardiovascular events
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 16
- 主要终点
- Annualised change in percentage plaque burden (Δ%PB) at End of Treatment (EoT)
研究概览
简要总结
To evaluate the effectiveness of the triple therapy in reducing plaque burden.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥22 years
- •Having provided informed consent for participation in this trial
- •Lipid-lowering treatment-naïve
- •Presence of extensive coronary atherosclerosis meeting all of the criteria below: - Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments18 (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease – reporting and data system (CAD-RADS)19 category 1, 2, or 3 - Not expected to be a candidate for revascularisation during the duration of the trial Note: Suspected obstructive coronary artery disease on PCD-CTA that was deemed non-obstructive during subsequent invasive coronary angiography (preferably assessed with invasive coronary physiology testing, e.g., fractional flow reserve), does not exclude patients from participating in the trial. - Untreated LDL-C ≥2.6 mmol/L and ≤4.5 mmol/L (where a diet without pharmacological treatment is considered ‘untreated')
- •Able to provide informed consent
排除标准
- •Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia
- •Pregnant or breastfeeding
- •Body mass index (BMI) >35 kg/m2
- •Anticipated life expectancy <52 weeks at the discretion of the local investigator
- •Requiring emergent procedures or having any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, severe congestive heart failure (New York Heart Association [NYHA] III or IV), or acute pulmonary oedema
- •Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out)
- •Complex congenital heart disease
- •Known or suspected severe valvular heart disease or valvular heart disease anticipated to require intervention within 52 weeks at the discretion of the local investigator
- •Cardiac arrythmia or tachycardia with significant likelihood of resulting in poor PCD-CTA image quality (especially atrial fibrillation or frequent premature beats)
- •Intracoronary stents
- •Prior pacemaker, internal defibrillator, or abandoned lead implantation
- •Myopathy or other known contraindication for BA, EZE, atorvastatin, and/or rosuvastatin. A participant with a contraindication for atorvastatin, can be assigned to triple therapy with rosuvastatin, and vice versa.
- •Prosthetic heart valves
- •Contraindications to contrast media or other medications needed for proper imaging (e.g., beta blockers and nitroglycerin)
- •Use of any experimental or investigational drug within 40 days or 5 half-lives prior to Screening (whichever is longer), or parallel participation in another interventional study
- •Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.
- •History of myocardial infarction, stroke, or peripheral artery disease (PAD), and/or coronary revascularisation (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG])
- •Significant stenosis in the left main artery (≥50%) or proximal LAD artery (≥70%), or 3-vessel coronary artery disease (≥70% stenosis in major branches), clinically indicated for revascularisation
- •Known significant liver disease (e.g., positive hepatitis B or hepatitis C serology) or significant hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 x upper limit of normal [ULN])
- •Known history of gout and/or uric acid levels at Screening ≥6.8 mg/dL
- •Known estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m² and/or receiving dialysis
- •Active malignancy (not including non-melanoma skin cancer)
研究组 & 干预措施
BEMPEDOIC ACID AND EZETIMIBE
Test
干预措施: BEMPEDOIC ACID AND EZETIMIBE (Drug)
ROSUVASTATIN
Test
干预措施: ROSUVASTATIN (Drug)
ATORVASTATIN
Test
干预措施: ATORVASTATIN (Drug)
结局指标
主要结局
Annualised change in percentage plaque burden (Δ%PB) at End of Treatment (EoT)
Annualised change in percentage plaque burden (Δ%PB) at End of Treatment (EoT)
次要结局
- Annualised change in normalised non-calcified PV at EoT (in mm3).
- Percentage of participants with regression in normalised TPV, normalised non-calcified PV, and normalised low attenuation PV at EoT (i.e., ΔPV and Δnon-calcified PV, and Δlow-attenuation PV).
- Change in the absolute Agatston coronary artery calcium (CAC) score at EoT.
- Relationship between the annualised change in LDL-C and the Δ%PB and Δ% non-calcified PB at EoT, as visualised by locally estimated scatterplot smoothing (LOESS) plot.
- Annualised ΔTPV (in mm3) at EoT.
- Percentage of participants with regression in TPV (i.e., negative ΔTPV) at EoT.
- • Absolute annualised change in fractional flow reserve derived from computed tomography (FFRCT) of the vessel with the lowest FFR at Baseline. • Absolute annualised change in FFRCT of the average of 3 main epicardial coronary arteries (left anterior descending artery [LAD], circumflex artery [Cx], right coronary artery [RCA]).
- Mean absolute changes in atherosclerosis-related biomarkers after 3 and 6 months and at EoT: total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides, lipoprotein (a) (Lp(a)), apolipoprotein B (apoB), and high-sensitive C reactive protein (hs-CRP).
- Annualised changes in Framingham steatosis index (FSI) and fibrosis-4 (Fib-4)
- Cumulative incidence of AEs under triple therapy during the trial.
- The rate of treatment discontinuation and the reasons for treatment discontinuation during the trial.
研究者
Katharina Wenz-Pöschl
Scientific
Daiichi Sankyo Europe GmbH
研究点 (16)
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