NCT07142265

Brief Summary

Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Sep 2025

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

August 19, 2025

Last Update Submit

April 13, 2026

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionNISinclisiran

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy

    Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events (cardiac death, nonfatal MI, nonfatal ischemic stroke, and hospitalization for unstable angina) registered within 12 months after the start of inclisiran therapy prescribed in addition to basic LLT

    12 months

Secondary Outcomes (14)

  • Change and absolute change in lipid profile parameters

    Baseline, month 3, month 9, month 12

  • Change and absolute change in lipid profile parameters in patients subgroups

    Baseline, month 3, month 9, month 12

  • Change in LDL-C level

    Baseline, Day 28

  • The proportion of patients who maintain the target LDL-C level

    Month 3, Month 12

  • The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L

    Day 28 , Month 12

  • +9 more secondary outcomes

Study Arms (1)

STEMI/Non-STEMI

Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI. Index event is a first diagnosed STEMI/non-STEMI.

You may qualify if:

  • Adult patients of both genders
  • Myocardial Infarction diagnosis
  • Dyslipidemia diagnosis
  • The first injection of inclisiran no later than 14 ± 5 days after the STEMI/non-STEMI
  • LDL-C \> 5 mmol/L (statin-naive patients) or LDL-C \> 2.5 mmol/L (on the basis of statin MTD) at the time of hospitalization or no target LDL-C level (\> 1.4 mmol/L or no LDL-C level decrease by 50% on statin MTD + ezetimibe)
  • Signed Informed Consent Form (ICF)

You may not qualify if:

  • Severe oncological and somatic diseases with system and organ failure\*
  • Competing diseases that caused emergency hospitalization (pulmonary thromboembolism, aortic dissection)
  • History of therapy with PCSK9 inhibitors
  • Active inflammatory liver disease or the levels of AST, ALT \> 3 times, or total bilirubin \> 2 times higher than the upper limit of norm
  • Any other MACE in the anamnesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Novartis Investigative Site

Cheboksary, 428000, Russia

RECRUITING

Novartis Investigative Site

Grozny, 364051, Russia

RECRUITING

Novartis Investigative Site

Kemerovo, 650002, Russia

RECRUITING

Novartis Investigative Site

Moscow, 105203, Russia

RECRUITING

Novartis Investigative Site

Moscow, 119607, Russia

RECRUITING

Novartis Investigative Site

Novosibirsk, 630051, Russia

RECRUITING

Novartis Investigative Site

Penza, 440026, Russia

RECRUITING

Novartis Investigative Site

Petrozavodsk, 185019, Russia

RECRUITING

Novartis Investigative Site

Rostov-on-Don, 344010, Russia

RECRUITING

Novartis Investigative Site

S Petersburg, 192242, Russia

RECRUITING

Novartis Investigative Site

Syktyvkar, 167981, Russia

RECRUITING

Novartis Investigative Site

Tomsk, 634009, Russia

RECRUITING

Novartis Investigative Site

Ulan-Ude, 670031, Russia

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(13)