Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients (STREAMLINE)

Novartis

Status: Enrolling

Conditions: Myocardial Infarction

Study type: Observational

Funder types: Industry

Identifiers

NCT07142265

CKJX839D1RU01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

300 participants in 1 patient group

STEMI/Non-STEMI

Description:

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