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Heart attack survivors: could a new shot clear your clogged arteries?

NCT ID NCT06372925

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

318 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Novartis Investigative Site

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    Fuzhou, Fujian, 350001, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518000, China

  • Novartis Investigative Site

    Zunyi, Guizhou, 563000, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150086, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430060, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Changchun, Jilin, 130033, China

  • Novartis Investigative Site

    Dalian, Liaoning, 116023, China

  • Novartis Investigative Site

    Jining, Shandong, 272000, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610072, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325027, China

  • Novartis Investigative Site

    Beijing, 101149, China

  • Novartis Investigative Site

    Lanzhou, 730000, China

  • Novartis Investigative Site

    Tianjin, 300000, China

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