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New treatment option for Plaque, Atherosclerotic
Official title Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT06372925
What this study is testing
What is atorvastatin?
atorvastatin is an investigational medicine, being studied as a potential treatment for plaque, atherosclerotic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female ≥ 18 and ≤ 75 years of age.
- Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI.
- At least 1 major, non-infarct-related coronary artery ("target vessel") meet all of the following criteria judged by the investigator: 1) Presence of...
- LDL-C \> 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.
- 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...
You likely can't join if
- Familial hypercholesterolemia or secondary hypercholesterolemia.
- Clinically instable AMI (hemodynamic or electrical instability).
- Left main disease, defined as ≥ 50% diameter stenosis of the left main coronary artery by coronary angiography.
- Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardial coronary vessels or in major branches of these arteries by coronary...
- Have a plan for treatment procedure within 12 months after signing ICF.
- Known intolerance to Atorvastatin OR known statin intolerance.
See the full eligibility criteria
- Male or female ≥ 18 and ≤ 75 years of age.
- Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI.
- 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...
- LDL-C \> 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.
- 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.
- Familial hypercholesterolemia or secondary hypercholesterolemia.
- Clinically instable AMI (hemodynamic or electrical instability).
- Left main disease, defined as ≥ 50% diameter stenosis of the left main coronary artery by coronary angiography.
- Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardial coronary vessels or in major branches of these arteries by coronary angiography.
- Have a plan for treatment procedure within 12 months after signing ICF.
- Known intolerance to Atorvastatin OR known statin intolerance.
- Patients already on high-intensity statin including atorvastatin 40 or 80 mg or rosuvastatin 20 mg upon signing ICF.
- Patients not suitable for IVUS/OCT evaluation (e.g., significant calcification , etc) judged by the investigator.
- Patients qualify for coronary artery bypass surgery at screening and history of coronary artery bypass surgery.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zunyi, Guizhou, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Jining, Shandong, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Lanzhou, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Zunyi, Guizhou, China; Harbin, Heilongjiang, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.