Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
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
This trial does not accept healthy volunteersQualifiers
Written informed consent (signed and dated).
Males and females aged ≥18 years.
history of MI;
history of IS and/or TIA;
Disqualifiers
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.
Trial population
Patients with the history of atherosclerotic cardiovascular disease (ASCVD). First-degree relatives of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Atorvastatin
Drug3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Simvastatin
Drug3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Rozuvastatin
Drug3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
Ezetimibe
DrugEzetimibe
Niacin
DrugNiacin
Ciprofibrate
DrugFibrates
Fenofibrate
DrugFibrates
Bezafibrate
DrugFibrates
Evolocumab
DrugPCSK9 inhibitor
Alirocumab
DrugPCSK9 inhibitor
Inclisiran
DrugSmall interfering RNA
Treatment groups
2,382 Participants
are divided into 2 treatment groupsGroup A: ASCVD patients11 interventions
Group B: Relatives of the ASCVD patients11 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients (%) with Lp(a) ≥125 nmol/L
Percentage of patients (%) with Lp(a) ≥125 nmol/L at baseline
Time frame
Baseline2
The difference in the number of patients with cardiovascular events (%) between the groups
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
Time frame
24 monthsSecondary outcomes
1
Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level
Percentage of patients (%) with at least one CVD by Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L \*CVD - Cardiovascular disease; ASCVD - Atherosclerotic cardiovascular disease
Time frame
Baseline2
Percentage of ASCVD patients (%) in accordance with the Lp(a) level
Percentage of ASCVD patients (%) by Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L
Time frame
Baseline3
Age of patients at the time of the first ASCVD in different subgroups in accordance with the Lp(a) level
Age of patients at the time of the first ASCVD in different subgroups by Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L
Time frame
Baseline4
Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level
Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level: ≤25 nmol/L, 25-75 nmol/L, 75-125 nmol/L, 125-188 nmol/L, 188-250 nmol/L, ≥250 nmol/L
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov