Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,382
- 试验地点
- 1
- 主要终点
- Percentage of patients (%) with Lp(a) ≥125 nmol/L
研究概览
简要总结
This study has the purpose to answer how the Lipoprotein(a) (Lp(a)) level is distributed among Atherosclerotic cardiovascular disease (ASCVD) patients in Russia, and what is the connection between elevated levels of this parameter and the cardiovascular disease (CVD) risk.
详细描述
This study will consist of several phases (consecutive stages):
Phase I: a cross-sectional study of Lp(a) level with ASCVD patients
Phase II:
- A non-interventional, prospective, cohort study with the phase I patients
- A cross-sectional study of Lp(a) levels with relatives of phase I patients
- A non-interventional, prospective, cohort study with patients' relatives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (signed and dated).
- •Males and females aged ≥18 years.
- •Presence of one of the following ASCVDs for at least 3 months within the 2 years prior to signing the informed consent to participate in this study:
- •history of MI;
- •history of IS and/or TIA;
- •IHD confirmed by coronary angiography (stenosis ≥50%);
- •any revascularization surgery (emergency or planned), including CABG, PCI, carotid endarterectomy or carotid/intracranial stenting;
- •peripheral artery disease (intermittent claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or revascularization in case of lower limb ischemia).
排除标准
- •Acute infectious and inflammatory diseases, such as COVID-19, in the month leading up to the Screening visit.
- •Lp(a)-lowering therapy/methods (Lp(a) apheresis with PCSK9 inhibitors, inclisiran prior to the Screening visit) in the medical history before the Screening visit.
- •Participation in any interventional clinical study with investigational or marketed medicinal products at the time of enrollment.
- •Participation in other real-world clinical studies.
- •Stages 4 and 5 of chronic kidney disease (glomerular filtration rate CKD-EPI <30 mL/min/1.73 m2) and/or hepatic disease (total bilirubin: 2 × ULN).
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Atorvastatin (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Simvastatin (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Rozuvastatin (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Ezetimibe (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Niacin (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Ciprofibrate (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Fenofibrate (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Bezafibrate (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Evolocumab (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Alirocumab (Drug)
ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
干预措施: Inclisiran (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Atorvastatin (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Simvastatin (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Rozuvastatin (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Ezetimibe (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Niacin (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Ciprofibrate (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Fenofibrate (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Bezafibrate (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Evolocumab (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Alirocumab (Drug)
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
干预措施: Inclisiran (Drug)
结局指标
主要结局
Percentage of patients (%) with Lp(a) ≥125 nmol/L
时间窗: Baseline
Percentage of patients (%) with Lp(a) ≥125 nmol/L at baseline
The difference in the number of patients with cardiovascular events (%) between the groups
时间窗: 24 months
The difference in the number of patients (%) with new cardiovascular events between the groups of patients with elevated Lp(a) ≥125 nmol/L and Lp(a) \<125 nmol/L
次要结局
- Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level(Baseline)
- Percentage of ASCVD patients (%) in accordance with the Lp(a) level(Baseline)
- Age of patients at the time of the first ASCVD in different subgroups in accordance with the Lp(a) level(Baseline)
- Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level(Baseline)
- Age of assignment of any disability group in different subgroups by the Lp(a) level(Baseline)
- Duration of temporary incapacity (sick leave) following the onset of CVE in different subgroups based on Lp(a) level(Baseline)
- Percentage of patients (%) without an official disability status who had to completely stop working after developing CVE in different subgroups based on Lp(a) level(Baseline)
- Lp(a) distribution level by a ASCVD type(Baseline)
- Percentage (%) of ASCVD patients with elevated Lp(a) levels by gender and age (20-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90 years)(Baseline)
- Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level(Baseline)
- Percentage of ASCVD patients (%) with elevated Lp(a) levels in groups stratified by the number of coronary arteries with hemodynamically significant stenosis in patients with relevant available data(Baseline)
- Percentage (%) of ASCVD patients with an elevated Lp(a) level classified depending on the presence of multifocal atherosclerosis, ischemic heart disease, and peripheral artery disease(Baseline)
- Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of MI events(Baseline)
- Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of IS and TIA events(Baseline)
- Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)(Baseline)
- Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first cardiovascular event (CVE)(Baseline)
- Percentage of ASCVD patients (%) with elevated Lp(a) levels by the PCI number (planned/emergency)(Baseline)
- Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level(Baseline)
- Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level(Baseline)
- Number of recurrent CVEs in different subgroups by the Lp(a) level(Baseline)
- Percentage of patients (%) with unstable angina, manifestations of TIA, PCI, and CABG in medical history (before the Screening visit) in different subgroups by the Lp(a) level(Baseline)
- Percentage of patients (%) with multiple CVE, such as unstable angina, TIA, PCI, and CABG (before or after the index/screening visit), in different subgroups based on Lp(a) level(Baseline)
- Percentage of patients (%) with severe CVE (MI, IS) (after the index/screening visit) based on the Lp(a) level in different subgroups(3, 9, 12, 18, and 24 months)
- Number of patients with recurrent CVEs (more than one event during the follow-up period) and the mean number of recurrent complications in the post-index visit period(3, 9, 12, 18, and 24 months)
- Percentage of patients (%) with cardiovascular deaths after the index/screening visit in different subgroups by the Lp(a) level(3, 9, 12, 18, and 24 months)
- Percentage of patients who died after the index/screening visit in different subgroups by the Lp(a) level(3, 9, 12, 18, and 24 months)
- Percentage of patients (%) who needed emergency medical care or visited a medical facility during the period following the index/screening visit in different subgroups by the Lp(a) level(3, 9, 12, 18, and 24 months)
- Number of emergency visits or visits to a medical facility following the index/screening visit in various subgroups by the Lp(a) level(3, 9, 12, 18, and 24 months)
- Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy(3, 9, 12, 18, and 24 months)
- Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels(3, 9, 12, 18, and 24 months)
- Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/(Baseline)
- Difference between groups in the number of relatives (%) with CVD complications during the 2-year observation period(24 months)