Actively Recruiting
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Led by Novartis Pharmaceuticals · Updated on 2025-08-03
2382
Participants Needed
20
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating how Lipoprotein(a) (Lp(a)) levels vary among patients with Atherosclerotic Cardiovascular Disease (ASCVD) in Russia and investigating the relationship between elevated Lp(a) levels and cardiovascular disease risk. The study aims to better understand the distribution of Lp(a) and its connection to cardiovascular events in this population. The study includes several phases: Phase I is a cross-sectional study measuring Lp(a) levels in ASCVD patients aged 18 and older. Phase II involves a non-interventional, prospective cohort study with these patients and their first-degree relatives, including parents and children with elevated Lp(a) levels. The study observes patients and relatives over time without altering their treatments. Participants will undergo assessments to measure Lp(a) levels and cardiovascular events at baseline and during follow-up visits up to 24 months. Researchers will collect clinical data, including disability status, cardiovascular events, hospitalizations, and lipid-lowering therapy usage. The study monitors the percentage of patients with elevated Lp(a), occurrence of cardiovascular complications, and treatment outcomes to understand the impact of Lp(a) levels on ASCVD progression and related health events.
CONDITIONS
Brief Title
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female aged 18 years or older.
- Diagnosis of atherosclerotic cardiovascular disease for at least 3 months within the past 2 years, including history of myocardial infarction, ischemic stroke or transient ischemic attack, ischemic heart disease confirmed by coronary angiography with at least 50% stenosis, any revascularization surgery, or peripheral artery disease with specific criteria.
You will not qualify if you...
- Acute infectious or inflammatory diseases, such as COVID-19, within one month before screening.
- Previous treatments to lower Lipoprotein(a), including PCSK9 inhibitors, apheresis, or inclisiran before screening.
- Participation in any interventional clinical trial with investigational or marketed drugs at enrollment.
- Participation in other real-world clinical studies.
- Advanced chronic kidney disease (stage 4 or 5) or significant liver disease (total bilirubin twice the upper limit of normal).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Cross-sectional at baseline
Participants undergo measurement of Lipoprotein(a) levels and assessment of cardiovascular health status.
1 visit (in-person)
Duration - 24 months
Participants are observed over 24 months to monitor cardiovascular events and related health outcomes.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 20 locations
1
Novartis Investigative Site
Chelyabinsk, Russia, 454048
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2
Novartis Investigative Site
Chelyabinsk, Russia, 454076
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3
Novartis Investigative Site
Kaluga, Russia, 248000
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4
Novartis Investigative Site
Kemerovo, Russia, 650002
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5
Novartis Investigative Site
Krasnoyarsk, Russia, 680022
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6
Novartis Investigative Site
Moscow, Russia, 119881
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7
Novartis Investigative Site
Moscow, Russia, 121552
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8
Novartis Investigative Site
Moscow, Russia, 125284
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9
Novartis Investigative Site
Omsk, Russia, 644024
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10
Novartis Investigative Site
Perm, Russia, 614002
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11
Novartis Investigative Site
Ryazan, Russia, 390039
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12
Novartis Investigative Site
Surgut, Russia, 628403
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13
Novartis Investigative Site
Tomsk, Russia, 634009
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14
Novartis Investigative Site
Tyumen, Russia, 625026
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15
Novartis Investigative Site
Vladimir, Russia, 600020
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16
Novartis Investigative Site
Vladivostok, Russia, 690000
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17
Novartis Investigative Site
Voronezh, Russia, 394018
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18
Novartis Investigative Site
Yakutsk, Russia, 677013
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19
Novartis Investigative Site
Yekaterinburg, Russia, 620137
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20
Novartis Investigative Site
Yekaterinburg, Russia, 620144
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Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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