Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by Coronary CTA (CCTA) and Microcalcification by F18-NaF PET: A Phase 3 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Noncalcified Coronary Artery Plaque Volume (NCPV)
研究概览
简要总结
This study will quantify changes in coronary plaque volumes and plaque composition in patients treated with evolocumab.
Previous intravascular ultrasound studies have shown that treatment with a lipid-lowering PCSK9 enzyme inhibitor, such as evolocumab, to be associated with a reduction of the fatty deposits that cause plaque in the arteries, however, it is not known how evolocumab affects specific coronary plaque types and plaque inflammation.
Investigators will use quantitative assessment of non-invasive coronary computed tomography angiography (CCTA) and positron emission tomography (PET)imaging to evaluate functional changes in plaque burden, plaque composition and vascular inflammation before and after treatment with evolocumab.
Investigators propose to show that patients treated with evolocumab in combination with statins demonstrate a greater reduction of coronary non-calcified plaque volume, thereby reducing the number of future cardiac events.
详细描述
To evaluate the effect of evolocumab, patients who are taking Evolocumab plus another cholesterol-lowering medication (e.g statins), will undergo diagnostic testing including non-invasive coronary CT angiographic (CCTA) scans and positron emission tomography (PET) scans. The CCTA and PET scans will be done before and after being treated with evolocumab.
At the initial visit, standard imaging eligibility screening will take place, as well as blood sampling to test cholesterol levels and presence of proteins (biomarkers) associated with heart disease. A CCTA will be done (if not done for clinical purposes within the past 90 days) and a PET scan with administration of 18F-NaF injection will take place. Patients will receive the first injection of evolocumab and will be taught how to self-inject once or twice a month for 18 months.
After the initial visit, patients will self-inject evolocumab at approximately 6, 12 and 18 months in front of a medical professional for site monitoring and re-training. Labs will be drawn to assess blood components related to heart disease.
Follow-up phone calls will be made at approximately 1,3, 9, 15 months and approximately 3-7 days after their final on-site visit (18 months) to monitor safety and drug adherence.
The final visit (18 months after the initial visit) will involve another PET scan, CCTA and blood collection for biomarker testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Evidence by CCTA of noncalcified coronary artery plaque (>440 mm3) and thoracic aorta atherosclerosis
- •On-label indications for evolocumab treatment which includes the following criteria:
- •Those who have established cardiovascular disease defined as acute coronary syndrome, history of myocardial infarction, stable angina or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin.
排除标准
- •Creatinine > 1.5 mg/dL prior to imaging
- •History of allergy to iodine contrast agents
- •Allergy to evolocumab or any other ingredients contained in study drug
- •Pregnancy
- •Women who are breastfeeding
- •Active atrial fibrillation
- •History of coronary artery bypass graft
- •Inability to lie flat
- •Inability or unwilling to give informed consent
- •Major illness or life expectancy <1 year
- •Planned coronary revascularization or major non-cardiac surgery in the next 12 months
- •Previously or currently on evolocumab
研究组 & 干预措施
Evolocumab, F18-NaF PET, CCTA
Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).
干预措施: Evolocumab (Drug)
Evolocumab, F18-NaF PET, CCTA
Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).
干预措施: 18F-NaF PET (Diagnostic Test)
Evolocumab, F18-NaF PET, CCTA
Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).
干预措施: CCTA (Diagnostic Test)
Evolocumab, F18-NaF PET, CCTA
Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).
干预措施: Omnipaque (Drug)
Evolocumab, F18-NaF PET, CCTA
Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).
干预措施: Metoprolol (Drug)
Evolocumab, F18-NaF PET, CCTA
Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Change in Noncalcified Coronary Artery Plaque Volume (NCPV)
时间窗: baseline (pre-treatment) and 18 months after of treatment
Compare NCPV in mm\^3 measured on cardiac CT images as analyzed by quantitative software between the two assessments
次要结局
- Change in Plaque Composition (Total, Calcified, Low Density Non Calcified)(baseline (pre-treatment) and 18 months after of treatment)
研究者
Daniel S. Berman
Principal Investigator/Chief Nuclear Cardiology and Cardiac Imaging
Cedars-Sinai Medical Center