Atherosclerotic Cardiovascular DiseaseSTaRTNCT06858332
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
An observational study of Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 20 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Atorvastatin, Simvastatin and Rozuvastatin
- How many people
- 2,382 participants
- Where
- 20 sitesRussia
- Study dates
- 15 Apr 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- Written informed consent (signed and dated).
- Males and females aged ≥18 years.
- 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).
Who cannot join
- 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.
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
20 sites in 1 country
Russia20 sites, 20 recruiting
- Recruiting
Novartis Investigative Site
Chelyabinsk, 454048
- Recruiting
Novartis Investigative Site
Chelyabinsk, 454076
- Recruiting
Novartis Investigative Site
Kaluga, 248000
- Recruiting
Novartis Investigative Site
Kemerovo, 650002
- Recruiting
Novartis Investigative Site
Krasnoyarsk, 680022
- Recruiting
Novartis Investigative Site
Moscow, 119881
- Recruiting
Novartis Investigative Site
Moscow, 121552
- Recruiting
Novartis Investigative Site
Moscow, 125284
- Recruiting
Novartis Investigative Site
Omsk, 644024
- Recruiting
Novartis Investigative Site
Perm, 614002
- Recruiting
Novartis Investigative Site
Ryazan, 390039
- Recruiting
Novartis Investigative Site
Surgut, 628403
- Recruiting
Novartis Investigative Site
Tomsk, 634009
- Recruiting
Novartis Investigative Site
Tyumen, 625026
- Recruiting
Novartis Investigative Site
Vladimir, 600020
- Recruiting
Novartis Investigative Site
Vladivostok, 690000
- Recruiting
Novartis Investigative Site
Voronezh, 394018
- Recruiting
Novartis Investigative Site
Yakutsk, 677013
- Recruiting
Novartis Investigative Site
Yekaterinburg, 620137
- Recruiting
Novartis Investigative Site
Yekaterinburg, 620144
About this study
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.
Read the detailed description
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
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Atorvastatin, Simvastatin, Rozuvastatin, Ezetimibe, Niacin
- Keywords
- lipoprotein(a),, ASCVD,, cardiovascular disease,, CVD
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
SimvastatinDrug
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
RozuvastatinDrug
3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins)
EzetimibeDrug
Ezetimibe
NiacinDrug
Niacin
CiprofibrateDrug
Fibrates
FenofibrateDrug
Fibrates
BezafibrateDrug
Fibrates
EvolocumabDrug
PCSK9 inhibitor
AlirocumabDrug
PCSK9 inhibitor
InclisiranDrug
Small interfering RNA
| Study group | Role | What they receive |
|---|---|---|
| ASCVD patients | Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization Receives: Drug: Atorvastatin; Drug: Simvastatin; Drug: Rozuvastatin; Drug: Ezetimibe; Drug: Niacin; Drug: Ciprofibrate; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Evolocumab; Drug: Alirocumab; Drug: Inclisiran | |
| Relatives of the ASCVD patients | A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L. Receives: Drug: Atorvastatin; Drug: Simvastatin; Drug: Rozuvastatin; Drug: Ezetimibe; Drug: Niacin; Drug: Ciprofibrate; Drug: Fenofibrate; Drug: Bezafibrate; Drug: Evolocumab; Drug: Alirocumab; Drug: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients (%) with Lp(a) ≥125 nmol/L
Percentage of patients (%) with Lp(a) ≥125 nmol/L at baseline
Measured: Baseline
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
Measured: 24 months
Secondary outcomes (32)
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Age of assignment of any disability group in different subgroups by the Lp(a) level
Age of assignment of any disability group in different subgroups 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
Measured: Baseline
Duration of temporary incapacity (sick leave) following the onset of CVE in different subgroups based on Lp(a) level
Duration of temporary incapacity (sick leave) following the onset of CVE (cardiovascular event) in different subgroups based on 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
Measured: Baseline
Percentage of patients (%) without an official disability status who had to completely stop working after developing CVE in different subgroups based on Lp(a) level
Percentage of patients (%) without an official disability status who had to completely stop working after developing CVE (cardiovascular event) in different subgroups based on 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
Measured: Baseline
Lp(a) distribution level by a ASCVD type
Percentage of patients with peripheral artery disease (PAD), ischemic stroke (IS), ischemic heart disease 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
Measured: Baseline
Percentage (%) of ASCVD patients with elevated Lp(a) levels by gender and age (20-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90 years)
Percentage (%) of ASCVD patients with elevated Lp(a) levels by gender and age (20-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90 years)
Measured: Baseline
Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level
Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups 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
Measured: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels in groups stratified by the number of coronary arteries with hemodynamically significant stenosis in patients with relevant available data
Percentage of ASCVD patients (%) with elevated Lp(a) levels in groups stratified by the number of coronary arteries with hemodynamically significant stenosis in patients with relevant available data
Measured: Baseline
Percentage (%) of ASCVD patients with an elevated Lp(a) level classified depending on the presence of multifocal atherosclerosis, ischemic heart disease, and peripheral artery disease
Percentage (%) of ASCVD patients with an elevated Lp(a) level classified depending on the presence of multifocal atherosclerosis, ischemic heart disease, and peripheral artery disease
Measured: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of MI events
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of myocardial infarction (MI) events
Measured: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of IS and TIA events
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of ischemic stroke (IS) and transient ischemic attack (TIA) events
Measured: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)
Measured: Baseline
Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first cardiovascular event (CVE)
Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first CVE (any of the following: myocardial infarction, ischemic stroke, transient ischemic attack, percutaneous coronary intervention, etc.)
Measured: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels by the PCI number (planned/emergency)
Percentage of ASCVD patients (%) with elevated Lp(a) levels by the percutaneous coronary intervention (PCI) number (planned/emergency)
Measured: Baseline
Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level
Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups 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
Measured: Baseline
Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level
Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups 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
Measured: Baseline
Number of recurrent CVEs in different subgroups by the Lp(a) level
Number of recurrent CVEs in different subgroups 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
Measured: Baseline
Percentage of patients (%) with unstable angina, manifestations of TIA, PCI, and CABG in medical history (before the Screening visit) in different subgroups by the Lp(a) level
Percentage of patients (%) with unstable angina, manifestations of transient ischemic attack (TIA), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG) in medical history (before the Screening visit) in different subgroups 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
Measured: Baseline
Percentage of patients (%) with multiple CVE, such as unstable angina, TIA, PCI, and CABG (before or after the index/screening visit), in different subgroups based on Lp(a) level
Percentage of patients (%) with multiple CVE, such as unstable angina, transient ischemic attack (TIA), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG) (before or after the index/screening visit), in different subgroups based on 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
Measured: Baseline
Percentage of patients (%) with severe CVE (MI, IS) (after the index/screening visit) based on the Lp(a) level in different subgroups
Percentage of patients (%) with severe CVE (MI, IS) based on 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 at 3, 9, 12, 18, and 24 months
Measured: 3, 9, 12, 18, and 24 months
Number of patients with recurrent CVEs (more than one event during the follow-up period) and the mean number of recurrent complications in the post-index visit period
Number of patients with recurrent CVEs (more than one event during the follow-up period) and the mean number of recurrent complications at 3, 9, 12, 18, and 24 months
Measured: 3, 9, 12, 18, and 24 months
Percentage of patients (%) with cardiovascular deaths after the index/screening visit in different subgroups by the Lp(a) level
Percentage of patients (%) with cardiovascular deaths in different subgroups 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 at 3, 9, 12, 18, and 24 months
Measured: 3, 9, 12, 18, and 24 months
Percentage of patients who died after the index/screening visit in different subgroups by the Lp(a) level
Percentage of patients who died in different subgroups 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 at 3, 9, 12, 18, and 24 months
Measured: 3, 9, 12, 18, and 24 months
Percentage of patients (%) who needed emergency medical care or visited a medical facility during the period following the index/screening visit in different subgroups by the Lp(a) level
Percentage of patients (%) who needed emergency medical care or visited a medical facility in different subgroups 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 at 3, 9, 12, 18, and 24 months
Measured: 3, 9, 12, 18, and 24 months
Number of emergency visits or visits to a medical facility following the index/screening visit in various subgroups by the Lp(a) level
Number of emergency visits or visits to a medical facility in various subgroups 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 at 3, 9, 12, 18, and 24 months
Measured: 3, 9, 12, 18, and 24 months
Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy
Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy
Measured: 3, 9, 12, 18, and 24 months
Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels
Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels
Measured: 3, 9, 12, 18, and 24 months
Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/
Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/L
Measured: Baseline
Difference between groups in the number of relatives (%) with CVD complications during the 2-year observation period
The difference in the number of relatives (%) with new cardiovascular events between the groups of patients with elevated Lp(a) ≥125 nmol/L and Lp(a) <125 nmol/L
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start15 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858332
- Sponsor's protocol ID
- CTQJ230A1RU01
- Acronym
- STaRT
- Status last verified
- Jul 2025
- First submitted
- 18 Feb 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
- ClinicalTrials.gov ID
- NCT06858332
- Acronym / sponsor ID
- STaRT / CTQJ230A1RU01
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- lipoprotein(a),, ASCVD,, cardiovascular disease,, CVD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,382 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASCVD patients | – | Drug: Atorvastatin, Drug: Simvastatin, Drug: Rozuvastatin, Drug: Ezetimibe, Drug: Niacin, Drug: Ciprofibrate, Drug: Fenofibrate, Drug: Bezafibrate, Drug: Evolocumab, Drug: Alirocumab, Drug: InclisiranPatients aged 18 and above with a history of ASCVD including peripheral arterial revascularization |
| Relatives of the ASCVD patients | – | Drug: Atorvastatin, Drug: Simvastatin, Drug: Rozuvastatin, Drug: Ezetimibe, Drug: Niacin, Drug: Ciprofibrate, Drug: Fenofibrate, Drug: Bezafibrate, Drug: Evolocumab, Drug: Alirocumab, Drug: InclisiranA first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (8 listed)
- Written informed consent (signed and dated).
- Males and females aged ≥18 years.
- 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:
Key exclusion criteria (6 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) | Drug | ASCVD patients, Relatives of the ASCVD patients |
| Simvastatin3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) | Drug | ASCVD patients, Relatives of the ASCVD patients |
| Rozuvastatin3-Hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) | Drug | ASCVD patients, Relatives of the ASCVD patients |
| EzetimibeEzetimibe | Drug | ASCVD patients, Relatives of the ASCVD patients |
| NiacinNiacin | Drug | ASCVD patients, Relatives of the ASCVD patients |
| CiprofibrateFibrates | Drug | ASCVD patients, Relatives of the ASCVD patients |
| FenofibrateFibrates | Drug | ASCVD patients, Relatives of the ASCVD patients |
| BezafibrateFibrates | Drug | ASCVD patients, Relatives of the ASCVD patients |
| EvolocumabPCSK9 inhibitor | Drug | ASCVD patients, Relatives of the ASCVD patients |
| AlirocumabPCSK9 inhibitor | Drug | ASCVD patients, Relatives of the ASCVD patients |
| InclisiranSmall interfering RNA | Drug | ASCVD patients, Relatives of the ASCVD patients |
Primary outcome
Percentage of patients (%) with Lp(a) ≥125 nmol/L
Time frame: Baseline
Percentage of patients (%) with Lp(a) ≥125 nmol/L at baseline
The difference in the number of patients with cardiovascular events (%) between the groups
Time frame: 24 months
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
32 secondary outcomes
Percentage of patients (%) with at least one CVD, and ASCVD number in different subgroups stratified by Lp(a) level
Time frame: Baseline
Percentage of ASCVD patients (%) in accordance with the Lp(a) level
Time frame: Baseline
Age of patients at the time of the first ASCVD in different subgroups in accordance with the Lp(a) level
Time frame: Baseline
Percentage of patients (%) with disability groups I, II, and III in different subgroups stratified by the Lp(a) level
Time frame: Baseline
Age of assignment of any disability group in different subgroups by the Lp(a) level
Time frame: Baseline
Duration of temporary incapacity (sick leave) following the onset of CVE in different subgroups based on Lp(a) level
Time frame: Baseline
Percentage of patients (%) without an official disability status who had to completely stop working after developing CVE in different subgroups based on Lp(a) level
Time frame: Baseline
Lp(a) distribution level by a ASCVD type
Time frame: Baseline
Percentage (%) of ASCVD patients with elevated Lp(a) levels by gender and age (20-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90 years)
Time frame: Baseline
Percentage of patients (%) with hemodynamically significant coronary atherosclerosis (stenosis ≥50%) in different subgroups by the Lp(a) level
Time frame: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels in groups stratified by the number of coronary arteries with hemodynamically significant stenosis in patients with relevant available data
Time frame: Baseline
Percentage (%) of ASCVD patients with an elevated Lp(a) level classified depending on the presence of multifocal atherosclerosis, ischemic heart disease, and peripheral artery disease
Time frame: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of MI events
Time frame: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different numbers of IS and TIA events
Time frame: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels classified into groups with different types of hospitalization (planned/emergency)
Time frame: Baseline
Percentage (%) of ASCVD patients with elevated Lp(a) levels classified by the first cardiovascular event (CVE)
Time frame: Baseline
Percentage of ASCVD patients (%) with elevated Lp(a) levels by the PCI number (planned/emergency)
Time frame: Baseline
Percentage of patients (%) with the first CVE (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level
Time frame: Baseline
Percentage of patients (%) with several CVEs (MI or IS) (before the Screening visit) in different subgroups by the Lp(a) level
Time frame: Baseline
Number of recurrent CVEs in different subgroups by the Lp(a) level
Time frame: Baseline
Percentage of patients (%) with unstable angina, manifestations of TIA, PCI, and CABG in medical history (before the Screening visit) in different subgroups by the Lp(a) level
Time frame: Baseline
Percentage of patients (%) with multiple CVE, such as unstable angina, TIA, PCI, and CABG (before or after the index/screening visit), in different subgroups based on Lp(a) level
Time frame: Baseline
Percentage of patients (%) with severe CVE (MI, IS) (after the index/screening visit) based on the Lp(a) level in different subgroups
Time frame: 3, 9, 12, 18, and 24 months
Number of patients with recurrent CVEs (more than one event during the follow-up period) and the mean number of recurrent complications in the post-index visit period
Time frame: 3, 9, 12, 18, and 24 months
Percentage of patients (%) with cardiovascular deaths after the index/screening visit in different subgroups by the Lp(a) level
Time frame: 3, 9, 12, 18, and 24 months
Percentage of patients who died after the index/screening visit in different subgroups by the Lp(a) level
Time frame: 3, 9, 12, 18, and 24 months
Percentage of patients (%) who needed emergency medical care or visited a medical facility during the period following the index/screening visit in different subgroups by the Lp(a) level
Time frame: 3, 9, 12, 18, and 24 months
Number of emergency visits or visits to a medical facility following the index/screening visit in various subgroups by the Lp(a) level
Time frame: 3, 9, 12, 18, and 24 months
Percentage of ASCVD patients (%) who achieved the target LDL-C level with the current lipid-lowering therapy
Time frame: 3, 9, 12, 18, and 24 months
Percentage of ASCVD patients (%) receiving lipid-lowering therapy, who experienced a change in Lp(a) levels
Time frame: 3, 9, 12, 18, and 24 months
Number of first-degree relatives (%) of patients with Lp(a) ≥125 nmol/
Time frame: Baseline
Difference between groups in the number of relatives (%) with CVD complications during the 2-year observation period
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Atherosclerotic Cardiovascular Disease
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 20 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients (%) with Lp(a) ≥125 nmol/L (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.