NCT04539223Unknown4 期
Study of Lipids Inside the Carotid With Evolocumab: A Randomized Trial of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy (SLICE-CEA CardioLink-8 Study)
Canadian Medical and Surgical Knowledge Translation Research Group3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in lipid rich necrotic core (LRNC) volume
研究概览
简要总结
This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years old
- •Significant (70-99%) carotid artery stenosis on one side, as measured by duplex ultrasound or angiogram
- •Asymptomatic carotid stenosis (no history of ipsilateral stroke or TIA within 180 days)
- •Deemed to be fit for carotid endarterectomy
- •At least one of the following high-risk features: (a) prior stroke >6months prior to randomization; (b) peripheral artery disease; (c) current smoker; (d) type 2 diabetes; (e) eGFR ≥ 30 mL/min/1.73m2 and <60 ml/min/1.73m2; (f) hsCRP > 2mg/L in the absence of alternative known causes of hsCRP elevations including autoimmune diseases or active infections.
- •On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified
排除标准
- •Contraindications for MRI (pacemaker; neurostimulator; non-removable metal fragments in the eye; etc.)
- •Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
- •Currently taking simvastatin >40mg/day
- •High risk comorbidities such as severe heart failure, severe COPD, severe renal disease, known severe hepatic impairment, unstable coronary syndrome, and/or advanced dementia
- •eGFR <30 mL/min/1.73m2
- •Current, prior within past year, or known planned use of PCSK9 inhibition treatment
- •Known intolerance or allergy to evolocumab or other PCSK9 inhibitors
- •Known latex allergy
- •Women who are pregnant or breastfeeding
- •Women of child bearing potential who are unwilling to use proper family planning or birth control methods to avoid pregnancy. Women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have had a surgical procedure such as hysterectomy which makes pregnancy impossible
- •Inability to comply with protocol-required study visits or procedures, including administration of study drug
- •Severe concomitant disease that is expected to reduce life expectancy to less than 5 years
- •Participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug
- •Additional Inclusion Criteria
- •If all eligibility criteria listed above are met, participants with only one high risk feature will undergo a time-of-flight MR angiogram, where one additional inclusion criteria will be assessed to confirm eligibility:
- •Evidence of IPH on MRI
研究组 & 干预措施
Drug (Evolocumab)
Active Comparator
Individuals randomized to this arm will administer Evolocumab subcutaneously (SC) every two weeks (Q2W) for 26 weeks.
干预措施: Evolocumab (Drug)
结局指标
主要结局
Change in lipid rich necrotic core (LRNC) volume
时间窗: Baseline to end of treatment (average of 6 months)
As measured by MRI
次要结局
- Change in vessel wall volume(Baseline to end of treatment (average of 6 months))
- Change in vessel lumen volume(Baseline to end of treatment (average of 6 months))
研究者
研究点 (3)
Loading locations...
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