Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
NCT ID: NCT06858332
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2382 participants
OBSERVATIONAL
2025-04-15
2027-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ASCVD patients
Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization
Atorvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Simvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Rozuvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Ezetimibe
Ezetimibe
Niacin
Niacin
Ciprofibrate
Fibrates
Fenofibrate
Fibrates
Bezafibrate
Fibrates
Evolocumab
PCSK9 inhibitor
Alirocumab
PCSK9 inhibitor
Inclisiran
Small interfering RNA
Relatives of the ASCVD patients
A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.
Atorvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Simvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Rozuvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Ezetimibe
Ezetimibe
Niacin
Niacin
Ciprofibrate
Fibrates
Fenofibrate
Fibrates
Bezafibrate
Fibrates
Evolocumab
PCSK9 inhibitor
Alirocumab
PCSK9 inhibitor
Inclisiran
Small interfering RNA
Interventions
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Atorvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Simvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Rozuvastatin
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Ezetimibe
Ezetimibe
Niacin
Niacin
Ciprofibrate
Fibrates
Fenofibrate
Fibrates
Bezafibrate
Fibrates
Evolocumab
PCSK9 inhibitor
Alirocumab
PCSK9 inhibitor
Inclisiran
Small interfering RNA
Eligibility Criteria
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Inclusion Criteria
2. Males and females aged ≥18 years.
3. 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).
Exclusion Criteria
2. 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.
3. Participation in any interventional clinical study with investigational or marketed medicinal products at the time of enrollment.
4. Participation in other real-world clinical studies.
5. 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).
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Kaluga, , Russia
Novartis Investigative Site
Kemerovo, , Russia
Novartis Investigative Site
Krasnoyarsk, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Omsk, , Russia
Novartis Investigative Site
Perm, , Russia
Novartis Investigative Site
Ryazan, , Russia
Novartis Investigative Site
Surgut, , Russia
Novartis Investigative Site
Tomsk, , Russia
Novartis Investigative Site
Tyumen, , Russia
Novartis Investigative Site
Vladimir, , Russia
Novartis Investigative Site
Vladivostok, , Russia
Novartis Investigative Site
Voronezh, , Russia
Novartis Investigative Site
Yakutsk, , Russia
Novartis Investigative Site
Yekaterinburg, , Russia
Novartis Investigative Site
Yekaterinburg, , Russia
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CTQJ230A1RU01
Identifier Type: -
Identifier Source: org_study_id
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