NCT06858332 Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
| NCT ID | NCT06858332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Atherosclerotic Cardiovascular Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,382 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,382 participants in total. It began in 2025-04-15 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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). Other protocol-defined inclusion/exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06858332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Atherosclerotic Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06858332 currently recruiting?
Yes, NCT06858332 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06858332 trial being conducted?
This trial is being conducted at Chelyabinsk, Russia, Chelyabinsk, Russia, Kaluga, Russia, Kemerovo, Russia and 11 additional locations.
Who is sponsoring the NCT06858332 clinical trial?
NCT06858332 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 2,382 participants.