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

Novartis

Status: Enrolling

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Drug: Niacin; Drug: Simvastatin; Drug: Fenofibrate; Drug: Inclisiran; Drug: Ezetimibe; Drug: Bezafibrate; Drug: Alirocumab; Drug: Evolocumab; Drug: Rozuvastatin; Drug: Ciprofibrate; Drug: Atorvastatin

Study type: Observational

Funder types: Industry

Identifiers

NCT06858332

CTQJ230A1RU01

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,382 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,382 participants in 2 patient groups

ASCVD patients

Description:

Patients aged 18 and above with a history of ASCVD including peripheral arterial revascularization

Treatment:

Drug: Atorvastatin

Drug: Ciprofibrate

Drug: Rozuvastatin

Drug: Evolocumab

Drug: Alirocumab

Drug: Bezafibrate

Drug: Ezetimibe

Drug: Inclisiran

Drug: Fenofibrate

Drug: Simvastatin

Drug: Niacin

Relatives of the ASCVD patients

Description:

A first-degree relative of the ASCVD patient (patient's parents and children) with Lp(a) ≥125 nmol/L.

Treatment:

Drug: Atorvastatin

Drug: Ciprofibrate

Drug: Rozuvastatin

Drug: Evolocumab

Drug: Alirocumab

Drug: Bezafibrate

Drug: Ezetimibe

Drug: Inclisiran

Drug: Fenofibrate

Drug: Simvastatin

Drug: Niacin