Actively Recruiting
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
Led by Novartis Pharmaceuticals · Updated on 2026-05-11
300
Participants Needed
16
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients of both genders
- Diagnosis of myocardial infarction
- Diagnosis of dyslipidemia
- First inclisiran injection within 14 �b1 5 days after STEMI or non-STEMI
- LDL-C > 5 mmol/L if statin-naive, or LDL-C > 2.5 mmol/L if on statin maximum tolerated dose, or no target LDL-C level (> 1.4 mmol/L or no LDL-C reduction by 50% on statin MTD plus ezetimibe) at hospitalization
- Signed informed consent form
You will not qualify if you...
- Severe cancer or other serious diseases causing system or organ failure
- Emergency hospitalization due to competing diseases like pulmonary thromboembolism or aortic dissection
- Previous therapy with PCSK9 inhibitors
- Active inflammatory liver disease or liver enzyme levels (AST, ALT) more than 3 times normal or total bilirubin more than 2 times normal
- History of any other major adverse cardiovascular event (MACE)
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Novartis Investigative Site
Cheboksary, Russia, 428000
Actively Recruiting
2
Novartis Investigative Site
Grozny, Russia, 364051
Actively Recruiting
3
Novartis Investigative Site
Kemerovo, Russia, 650002
Actively Recruiting
4
Novartis Investigative Site
Khanty-Mansiysk, Russia, 628012
Actively Recruiting
5
Novartis Investigative Site
Moscow, Russia, 105203
Actively Recruiting
6
Novartis Investigative Site
Moscow, Russia, 119607
Actively Recruiting
7
Novartis Investigative Site
Moscow, Russia, 121552
Actively Recruiting
8
Novartis Investigative Site
Novosibirsk, Russia, 630051
Actively Recruiting
9
Novartis Investigative Site
Penza, Russia, 440026
Actively Recruiting
10
Novartis Investigative Site
Petrozavodsk, Russia, 185019
Actively Recruiting
11
Novartis Investigative Site
Rostov-on-Don, Russia, 344010
Actively Recruiting
12
Novartis Investigative Site
S Petersburg, Russia, 192242
Actively Recruiting
13
Novartis Investigative Site
Samara, Russia, 443070
Actively Recruiting
14
Novartis Investigative Site
Syktyvkar, Russia, 167981
Actively Recruiting
15
Novartis Investigative Site
Tomsk, Russia, 634009
Actively Recruiting
16
Novartis Investigative Site
Ulan-Ude, Russia, 670031
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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