Heart attack survivors: could a new shot clear your clogged arteries?
NCT ID NCT06372925
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study tests if a drug called inclisiran can reduce fatty plaque buildup in the arteries of people who recently had a heart attack and have high cholesterol. About 318 adults will receive either inclisiran or standard care, and doctors will use special imaging to measure plaque changes over one year. The goal is to see if this treatment can help control heart disease and prevent future problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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318 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female ≥ 18 and ≤ 75 years of age. 2. Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI. 3. At least 1 major, non-infarct-related coronary artery ("target vessel") meet all of the following criteria judged by the investigator: 1\) Presence of atherosclerotic plaque with ≥ 20% and ≤ 50% diameter stenosis by coronary angiography. 2\) Target vessel deemed to be accessible to imaging catheters and suitable for intravascular imaging in the proximal (50 mm) segment ("target segment") 3) Target vessel is suitable for IVUS and OCT evaluation. 4) Not have undergone previous PCI within target vessel. 5) Not be a bypass graft or a bypassed native vessel. 4. Rapid LDL-C test value at screening period of: 1. LDL-C \> 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF. 2. LDL-C \> 2.6 mmol/L if not on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF. 5\. Written informed consent must be obtained. Exclusion Criteria: 1. Familial hypercholesterolemia or secondary hypercholesterolemia. 2. Clinically instable AMI (hemodynamic or electrical instability). 3. Left main disease, defined as ≥ 50% diameter stenosis of the left main coronary artery by coronary angiography. 4. Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardial coronary vessels or in major branches of these arteries by coronary angiography. 5. Have a plan for interventional procedure within 12 months after signing ICF. 6. Known intolerance to Atorvastatin OR known statin intolerance. 7. Patients already on high-intensity statin including atorvastatin 40 or 80 mg or rosuvastatin 20 mg upon signing ICF. 8. Patients not suitable for IVUS/OCT evaluation (e.g., significant calcification , etc) judged by the investigator. 9. Patients qualify for coronary artery bypass surgery at screening and history of coronary artery bypass surgery. 10. Cardiac disorders: 1\) Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening; 2) Pacemaker or ICD in situ; and/or 3) Uncontrolled severe hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy. 11\. Rapid lipid test triglyceride (TG) level \> 400mg/dL (4.5 mmol/L) at screening. 12\. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \> 3x the upper limit of normal (ULN), or total bilirubin \> 2x ULN before the randomization. 13\. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2(Calculated according to the modified MDRD equation). 14\. Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years. 15\. Previous (within 90 days before randomization), current or planned treatment with a PCSK9 monoclonal antibody (mAb). 16\. Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy 2 years prior to randomization. 17\. Participation in another investigational device or drug study currently, or within 5 half-live (if drug) or 30 days whichever is longer, prior to randomization. 18\. History of hypersensitivity to any study drug or its excipients. 19. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and/or put the participant at significant risk according to investigator's judgment. 20\. Pregnant or nursing (lactating) women. 21. Women of child-bearing potential, unless they are using effective methods of contraception during study treatment. 22\. Any conditions that according to the investigator could interfere with the conduct of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Novartis Investigative Site
Hefei, Anhui, 230001, China
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Novartis Investigative Site
Fuzhou, Fujian, 350001, China
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Novartis Investigative Site
Guangzhou, Guangdong, 510000, China
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Novartis Investigative Site
Guangzhou, Guangdong, 510080, China
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Novartis Investigative Site
Shenzhen, Guangdong, 518000, China
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Novartis Investigative Site
Zunyi, Guizhou, 563000, China
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Novartis Investigative Site
Harbin, Heilongjiang, 150086, China
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Novartis Investigative Site
Zhengzhou, Henan, 450003, China
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Novartis Investigative Site
Wuhan, Hubei, 430060, China
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Novartis Investigative Site
Nanchang, Jiangxi, 330006, China
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Novartis Investigative Site
Changchun, Jilin, 130033, China
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Novartis Investigative Site
Dalian, Liaoning, 116023, China
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Novartis Investigative Site
Jining, Shandong, 272000, China
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Novartis Investigative Site
Xian, Shanxi, 710061, China
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Novartis Investigative Site
Chengdu, Sichuan, 610072, China
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Novartis Investigative Site
Wenzhou, Zhejiang, 325027, China
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Novartis Investigative Site
Beijing, 101149, China
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Novartis Investigative Site
Lanzhou, 730000, China
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Novartis Investigative Site
Tianjin, 300000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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