EUCTR2018-002483-11-GB进行中（未招募）1 期
CHOlesterol Reduction with Evolocumab and coronAry microvascuLar function: The CHORAL Study - Evolocumab and coronary flow: The CHORAL Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients aged between 18 and 80 years, with a clinical indication for coronary angiography and:
- •1.Willing to provide consent: Provide written (signed and dated) informed consent and be capable of understanding the study and co-operating with treatment and follow-up.
- •2.Raised levels of fasting (>9h) LDL-cholesterol (=2mmol/L) either on optimal statin therapy (90% of overall sample) or intolerants to statins (restricted to 10% of overall sample) and
- •3.At least one other risk factor for vascular disease or established vascular disease.
- •Optimal statin therapy will be defined as at least 4 weeks of atorvastatin 40mg or more, with no change in statin dose during this period.
- •Definition of vascular risk factors
- •1.Diabetes (type I or type II), formally diagnosed, on therapy;
- •2.Current cigarette smoking;
- •3.Diagnosis of hypertension, on treatment;
- •4.Early family history of established vascular disease (brother or father with vascular disease before 55yo or sister or mother with vascular disease before 65yo);
- •5.Most recent LDL-C = 3.4 mmol/L despite at least 40mg of atorvastatin.
- •Definition of established vascular disease
- •1.Previously documented coronary disease, stable or unstable.
- •1.1History of acute coronary syndrome;
- •1.2Previous coronary revascularisation;
- •1.3Clinical syndrome of stable angina;
- •1.4Previous documented at least one moderate coronary stenosis on coronary angiography.
- •2.Previously formally diagnosed symptomatic peripheral vascular disease;
- •3.Previously documented cerebrovascular ischaemic event;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients unable or unwilling to provide written informed consent;
- •2.Patients unable to undergo cardiac catheterisation;
- •3.Patients with severe asthma (contraindication to adenosine);
- •4.Uncontrolled hypertension (systolic BP >180mmHg or DBP >110mmHg, despite ongoing therapy);
- •5.Clinical heart failure NYHA class III/IV or Ejection Fraction on imaging modality (Echo, MRI) <40%;
- •6.Severe valvular heart disease;
- •7.Severe (>95% diameter) epicardial coronary stenosis;
- •8.Recent (last 12 months) clinically significant cerebrovascular event (including ischaemic or haemorrhagic events);
- •9.End-stage renal failure (eGFR < 20 mL/min/1.73m2);
- •10.Advanced liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x ULN
- •11. Current use of PCSK9 inhibitor;
- •12.Malignancy with life expectancy <1y;
- •13.Currently or within last 3 months enrolled on another CTIMP;
- •14.Known allergy to evolocumab or recipients;
- •15.Female subject who has either (1) not used acceptable method(s) of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment with IP and for an additional 15 weeks after the end of treatment with IP, unless the subject is sterilized or postmenopausal;
- •15.1.Menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female = 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle-stimulating hormone (FSH) level > 40 IU/L (or according to the definition of postmenopausal range for the laboratory involved) in a female < 55 years old unless the subject has undergone bilateral oophorectomy.
- •15.2.Acceptable methods of preventing pregnancy include not having intercourse, birth control pills, injections, implants, or patches, intrauterine devices (IUDs), tubal ligation/occlusion, sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with Spermicide
- •16.Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed during treatment with IP and/ or within 15 weeks after the end of treatment with IP
研究者
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