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RECRUITINGNCT06858332

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

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 ele...

Lead sponsor: Novartis Pharmaceuticals•20 locations•View source on ClinicalTrials.gov

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Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Sponsors

Lead Sponsor

Novartis Pharmaceuticals

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Written informed consent (signed and dated).
•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

•1. Acute infectious and inflammatory diseases, such as COVID-19, in the month leading up to the Screening visit.
•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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 3, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment2,382

Start dateApr 2025

Last updatedAug 3, 2025

Condition

Atherosclerotic Cardiovascular Disease

Locations shown

Novartis Investigative Site

Chelyabinsk

Novartis Investigative Site

Chelyabinsk

Novartis Investigative Site

Kaluga

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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