2024-519012-14-00招募中2 期
Effect of impact of PCSK9 inhibitor on coronary microvascular dysfunction in patients with atherosclerotic cardiovascular disease needing coronarography.
Centre Hospitalier Universitaire Grenoble Alpes1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年11月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Index of microcirculatory resistance (IMR), measured during invasive coronary angiography (ICA) (in mmHg.s).
研究概览
简要总结
To compare coronary microvascular dysfunction (CMVD) 4-week after a single administration with evolocumab or without treatment, in patients with atherosclerotic cardiovascular disease proved by noninvasive imaging test and needing coronarography.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, aged 40 to 85
- •More than 50 kilograms
- •LDL-C level ≥ 0.7 g / L (biological assessment of less than 6 months)
- •For which coronarography is indicated according to European guidelines
- •Affiliated with social security
- •Signed informed consent form
排除标准
- •Clinical presentation of unstable angina
- •Actual use of PCSK9 inhibitior (evolucumab or others)
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN at screening
- •LDL apheresis within 12 months prior to randomization
- •Active infection or others active disease judge by investigator incompatible with the protocole completion
- •Known sensitivity to evolocumab or their excipients to be administered during dosing or natural rubber / latex
- •Patient likely to not be available to complete all protocol-required study visits or procedures.
- •Patient in exclusion period of another study
- •Woman able to procreate in the absence of highly effective contraception
- •Persons referred to in Articles L1121-6 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)
- •Patient whose state of physical or psychological health could compromise the obtaining of his informed consent and his compliance with the requirements of the protocol, with the study evaluation, procedures or completion.
- •End stage disease (estimated survival of less than one year)
- •Severe renal dysfunction, defined as an estimated creatinine clearance (MDRD) < 30 mL/min at screening
- •Contra-indication to adenosin : hypersensitivity to active active substance or to any of the excipients, type II or III atrioventricular block or atrial disease (except for pacemaker users), long QT syndrome, severe arterial hypotension, acute heart failure, asthma and severe chronic obstructive pulmonary disease, unstable angina unstabilized by drug therapy, taking dipyridamole, aminophylline, theophylline or other xanthine base within 24 hours prior to adenosine administration
- •Contra-indication to heparin: hypersensitivity to active substance or to any of the excipients, past heparin induced thrombopenia type II, haemorrhage.
- •Prior myocardial infarction in the territory needing coronary microcirculation measurement
- •NYHA class III or IV, or last known left ventricular ejection fraction < 30%
结局指标
主要结局
Index of microcirculatory resistance (IMR), measured during invasive coronary angiography (ICA) (in mmHg.s).
Index of microcirculatory resistance (IMR), measured during invasive coronary angiography (ICA) (in mmHg.s).
次要结局
- Troponin I level after PCI.
- Coronary angiography parameters and coronary physiology: % epicardial stenosis, FFR, CFR, IMR
- Resting ultrasound parameters: systolic and diastolic function, myocardial deformation.
研究者
BARONE-ROCHETTE Gilles
Scientific
Centre Hospitalier Universitaire Grenoble Alpes
研究点 (1)
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