Myocardial InfarctionSTREAMLINENCT07142265
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
An observational study of Myocardial Infarction, run by Novartis Pharmaceuticals at 18 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myocardial Infarction
- How many people
- 300 participants
- Where
- 18 sitesRussia
- Study dates
- 30 Sep 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
18 sites in 1 country
Russia18 sites, 18 recruiting
- Recruiting
Novartis Investigative Site
Cheboksary, 428000
- Recruiting
Novartis Investigative Site
Grozny, 364051
- Recruiting
Novartis Investigative Site
Kaluga, 248000
- Recruiting
Novartis Investigative Site
Kemerovo, 650002
- Recruiting
Novartis Investigative Site
Khanty-Mansiysk, 628012
- Recruiting
Novartis Investigative Site
Moscow, 105203
- Recruiting
Novartis Investigative Site
Moscow, 119607
- Recruiting
Novartis Investigative Site
Moscow, 121552
- Recruiting
Novartis Investigative Site
Novosibirsk, 630051
- Recruiting
Novartis Investigative Site
Orenburg, 460018
- Recruiting
Novartis Investigative Site
Penza, 440026
- Recruiting
Novartis Investigative Site
Petrozavodsk, 185019
- Recruiting
Novartis Investigative Site
Rostov-on-Don, 344010
- Recruiting
Novartis Investigative Site
S Petersburg, 192242
- Recruiting
Novartis Investigative Site
Samara, 443070
- Recruiting
Novartis Investigative Site
Syktyvkar, 167981
- Recruiting
Novartis Investigative Site
Tomsk, 634009
- Recruiting
Novartis Investigative Site
Ulan-Ude, 670031
About this study
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
- Myocardial Infarction
- Keywords
- Myocardial infarction, NIS, inclisiran
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI/Non-STEMI | Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (14)
Change and absolute change in lipid profile parameters
Change and absolute change in lipid profile parameters (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides, lipoprotein (a)) at 3, 9, and 12 months
Measured: Baseline, month 3, month 9, month 12
Change and absolute change in lipid profile parameters in patients subgroups
Change and absolute change in lipid profile parameters at 3, 9, and 12 months in each of the 3 groups of patients identified on the basis of therapy and LDL-C level at admission:
- Patients who have not previously received statins, with LDL-C level > 5 mmol/L;
- Patients receiving MTD statin therapy with LDL-C level of > 2.5 mmol/L;
- Patients receiving MTD statin therapy + ezetimibe who not at LDL-C target (> 1.4 mmol/L) or did not achieve a 50% reduction in LDL-C level
Measured: Baseline, month 3, month 9, month 12
Change in LDL-C level
Change in LDL-C level at Day 28 from baseline
Measured: Baseline, Day 28
The proportion of patients who maintain the target LDL-C level
The proportion of patients who maintain the target LDL-C level achieved after 3 months throughout the study period (12 months)
Measured: Month 3, Month 12
The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L
The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L at Day 28 and at 12 months
Measured: Day 28 , Month 12
The proportion of patients with progression and regression/no changes in atherosclerotic plaque
The proportion of patients with progression and regression/no changes in atherosclerotic plaque determined on the basis of changes in its maximum height (mm) by carotid ultrasound at 12 months compared to 3-5 days after ACS (Acute Coronary Syndrome)
Measured: Baseline, Month 12
Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm)
The correlation between the achievement of the target LDL-C level of < 1.4 mmol/L and a change in the maximum plaque height (mm) is going to be measured.
Measured: 12 months
Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE)
Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) at 3, 9, and 12 months
Measured: Month 3, Month 9, Month 12
The number of patients who discontinued inclisiran therapy due to AEs
The number of patients who discontinued inclisiran therapy due to AEs at 3, 9, and 12 months
Measured: Month 3, Moth 9, Month 12
The number of patients re-hospitalized for CV events during the year
The number of patients re-hospitalized for cardiovascular (CV) events during the year
Measured: 12 months
The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization
The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization
Measured: 12 months
Number of patients who sought emergency care after the baseline visit
Number of patients who sought emergency care after the baseline visit
Measured: 12 months
The number of patients placed under dispensary observation
The number of patients placed under dispensary observation
Measured: 12 months
Number of days from the date of hospital discharge to place under dispensary observation
Number of days from the date of hospital discharge to place under dispensary observation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start30 Sep 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 Myocardial InfarctionStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142265
- Sponsor's protocol ID
- CKJX839D1RU01
- Acronym
- STREAMLINE
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
- ClinicalTrials.gov ID
- NCT07142265
- Acronym / sponsor ID
- STREAMLINE / CKJX839D1RU01
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, NIS, inclisiran
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI/Non-STEMI | – | –Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy
Time frame: 12 months
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
14 secondary outcomes
Change and absolute change in lipid profile parameters
Time frame: Baseline, month 3, month 9, month 12
Change and absolute change in lipid profile parameters in patients subgroups
Time frame: Baseline, month 3, month 9, month 12
Change in LDL-C level
Time frame: Baseline, Day 28
The proportion of patients who maintain the target LDL-C level
Time frame: Month 3, Month 12
The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L
Time frame: Day 28 , Month 12
The proportion of patients with progression and regression/no changes in atherosclerotic plaque
Time frame: Baseline, Month 12
Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm)
Time frame: 12 months
Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE)
Time frame: Month 3, Month 9, Month 12
The number of patients who discontinued inclisiran therapy due to AEs
Time frame: Month 3, Moth 9, Month 12
The number of patients re-hospitalized for CV events during the year
Time frame: 12 months
The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization
Time frame: 12 months
Number of patients who sought emergency care after the baseline visit
Time frame: 12 months
The number of patients placed under dispensary observation
Time frame: 12 months
Number of days from the date of hospital discharge to place under dispensary observation
Time frame: 12 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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Novartis Pharmaceuticals at 18 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 6 inclusion and 5 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy (time frame: 12 months). 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 10 Aug 2026.