Actively Recruiting
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
Led by Novartis Pharmaceuticals · Updated on 2026-04-14
334
Participants Needed
20
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C).
CONDITIONS
Official Title
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 75 years of age
- Diagnosed with acute myocardial infarction (STEMI within 24 hours or NSTEMI within 72 hours) with planned PCI
- Have at least one major non-infarct coronary artery with 20% to 50% diameter stenosis suitable for IVUS and OCT imaging
- LDL-C greater than 1.8 mmol/L if on stable statin dose for at least 4 weeks
- LDL-C greater than 2.6 mmol/L if not on stable statin dose for at least 4 weeks
- Provided written informed consent
You will not qualify if you...
- Familial or secondary hypercholesterolemia
- Clinically unstable acute myocardial infarction
- Left main coronary artery disease with 50% or greater stenosis
- Three-vessel coronary artery disease with 70% or greater stenosis in major vessels
- Planned interventional procedure within 12 months
- Known intolerance to atorvastatin or statins
- Currently on high-intensity statin therapy
- Unsuitable for IVUS or OCT evaluation
- Eligible for or history of coronary artery bypass surgery
- Uncontrolled arrhythmias or pacemaker/ICD implanted
- Uncontrolled severe hypertension despite treatment
- Triglycerides over 400 mg/dL at screening
- Active liver disease or abnormal liver tests
- Estimated glomerular filtration rate below 30 mL/min/1.73m2
- Severe non-cardiovascular disease limiting life expectancy to less than 2 years
- Recent or planned treatment with PCSK9 monoclonal antibodies or Inclisiran
- Participation in another investigational study recently
- Allergy to study drugs or their ingredients
- Any uncontrolled serious medical or surgical condition
- Pregnant or nursing women
- Women of child-bearing potential not using effective contraception
- Any other condition that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Novartis Investigative Site
Hefei, Anhui, China, 230001
Actively Recruiting
2
Novartis Investigative Site
Fuzhou, Fujian, China, 350001
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3
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
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4
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
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5
Novartis Investigative Site
Guangzhou, Guangdong, China, 510080
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6
Novartis Investigative Site
Shenzhen, Guangdong, China, 518000
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7
Novartis Investigative Site
Zunyi, Guizhou, China, 563000
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8
Novartis Investigative Site
Harbin, Heilongjiang, China, 150086
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9
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
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10
Novartis Investigative Site
Wuhan, Hubei, China, 430060
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11
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
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12
Novartis Investigative Site
Changchun, Jilin, China, 130033
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13
Novartis Investigative Site
Dalian, Liaoning, China, 116023
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14
Novartis Investigative Site
Jining, Shandong, China, 272000
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15
Novartis Investigative Site
Xian, Shanxi, China, 710061
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16
Novartis Investigative Site
Chengdu, Sichuan, China, 610072
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17
Novartis Investigative Site
Wenzhou, Zhejiang, China, 325027
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18
Novartis Investigative Site
Beijing, China, 101149
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19
Novartis Investigative Site
Lanzhou, China, 730000
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20
Novartis Investigative Site
Tianjin, China, 300000
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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