NCT03851263撤回4 期
Multi-slice CT Scan Assessment of the Impact of PCSK9 Inhibition With Evolocumab on Coronary Perfusion in Patients With Reduced Coronary Fractional Flow Reserve (FFR).
ECRI bv0 个研究点开始时间: 2019年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Mean change in normalized area under the curve of fractional flow reserve derived from coronary computed tomography(CCTA) (FFRCT) at 18 months from baseline
研究概览
简要总结
The MARKOV study is an investigator-sponsored single arm, prospective study to assess the effect of evolocumab on the improvement in coronary flow (FFRCT) after 18 and 36 months of treatment in patients with coronary atherosclerosis.
详细描述
The MARKOV study is an investigator-initiated, open-label, single arm, international, multicenter, prospective study to assess the effect of evolocumab on the improvement in coronary flow (FFRCT) after 18 and 36 months of treatment in patients with coronary atherosclerosis. The study will be conducted in 5 sites in 3 different countries in Europe. Patients will receive evolocumab for approximately 3 year. The expected duration of the entire study from First Subject First Visit to Last Subject Last Follow-up is 46 months (3 year and 10 months).
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
- •At least 2 coronary vessels suitable for CCTA; vessels fulfilling all requirements below: a. patent main branch b. no previous stent placement
- •At least two of the evaluable vessels with subclinical coronary artery disease as defined non-invasively by CCTA with encroachment of the vessel and either: a. Lesion with visual diameter stenosis (DS) < 50% or, b. Lesion with visual DS ≥ 50% and FFRCT > 0.80;
- •No planned coronary revascularization (during the course of the study) at the time of enrollment;
- •Most recent, taken within 30 days prior to informed consent form (ICF) signature, fasting LDL-C ≥ 80 mg/dL (≥ 2.07 mmol/L) and on stable statin therapy for at least 30 days at the time of blood sampling, or statin-intolerant or for whom a statin is contraindicated.
- •Subject signed informed consent form
排除标准
- •History of coronary artery bypass surgery, heart transplantation, surgical or percutaneous valve repair and/or replacement
- •New York Heart Association (NYHA) class III or IV heart failure
- •Last known left ventricular ejection fraction <30%
- •Active liver disease or hepatic dysfunction, either known or defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN)
- •Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- •Active malignancy except for adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm (e.g. successfully treated cervical cancer in situ or non-active prostate cancer) Imaging CCTA-related
- •Absence of baseline CCTA obtained in the context of standard clinical care
- •Baseline CCTA not meeting Core Lab quality standards
- •Any contraindication for repeat CCTA such as known anaphylactic allergy to iodinated contrast
- •Concomitant and study medication
- •Any prior or current use of PCSK9 inhibition treatment or any other experimental lipid-related drug Other exclusion criteria
- •LDL or plasma apheresis within 12 months of screening
- •Subject < 18 years of age
- •Legally incompetent to provide written informed consent;
- •Known pregnancy or breast-feeding at time of screening
- •Female subject of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause)
- •Male subject with female partner of childbearing potential who is not using highly effective birth control
- •Currently participating in another trial
研究组 & 干预措施
Evolocumab
Experimental
All subjects are treated with evolocumab 140mg every 2 weeks (q2w) starting on day 1 and ending on day 1071 (week 153).
干预措施: Evolocumab (Biological)
结局指标
主要结局
Mean change in normalized area under the curve of fractional flow reserve derived from coronary computed tomography(CCTA) (FFRCT) at 18 months from baseline
时间窗: 18 months of treatment
次要结局
- Percent change of total atheroma burden (TAB) and changes in plaque composition at 18 and 36 months measured by Hounsfield unit of plaque with positive remodeling (>1.10) assessed by coronary computed tomography.(18 and 36 months of treatment)
- Number of treatment emergent adverse events (TEAEs) and adverse events (AEs) of special interest (i.e. acute kidney injury, pregnancy and lactation)(36 months of treatment)
- Incidence of all-cause death and the composite of Cardiovascular death, myocardial infarction, stroke, or coronary revascularization. The composite of Cardiovascular death, Myocardial infarction, or stroke(36 months of treatment)
- Mean change in normalized area under the curve of fractional flow reserve derived from coronary computed tomography (FFRCT) at 36 months from baseline.(36 months of treatment)
- Change and percent change after 18 and 36 months from baseline of total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), lipoprotein (a), triglycerides, apolipoprotein A1 and B.(18 and 36 months of treatment)
研究者
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