Phase
Condition
Angina
Heart Defect
Coronary Artery Disease
Treatment
inclisiran
IVUS/OCT
atorvastatin
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female ≥ 18 and ≤ 75 years of age.
Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) withplanned PCI.
At least 1 major, non-infarct-related coronary artery ("target vessel") meet all ofthe following criteria judged by the investigator:
Presence of atherosclerotic plaque with ≥ 20% and ≤ 50% diameter stenosis bycoronary angiography.
Target vessel deemed to be accessible to imaging catheters and suitable forintravascular imaging in the proximal (50 mm) segment ("target segment") 3) Targetvessel is suitable for IVUS and OCT evaluation. 4) Not have undergone previous PCIwithin target vessel. 5) Not be a bypass graft or a bypassed native vessel. 4. RapidLDL-C test value at screening period of:
LDL-C > 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4weeks 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.
Written informed consent must be obtained.
Exclusion
Exclusion Criteria:
Familial hypercholesterolemia or secondary hypercholesterolemia.
Clinically instable AMI (hemodynamic or electrical instability).
Left main disease, defined as ≥ 50% diameter stenosis of the left main coronaryartery by coronary angiography.
Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardialcoronary vessels or in major branches of these arteries by coronary angiography.
Have a plan for interventional 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 orrosuvastatin 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 ofcoronary artery bypass surgery.
Cardiac disorders:
- Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventriculartachycardia or atrial fibrillation with rapid ventricular response not controlled bymedications 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 ordiastolic blood pressure >110 mmHg prior to randomization despite antihypertensivetherapy.
Rapid lipid test triglyceride (TG) level > 400mg/dL (4.5 mmol/L) at screening.
Active liver disease defined as any known current infectious, neoplastic, ormetabolic pathology of the liver or unexplained elevations in alanineaminotransferase (ALT), aspartate aminotransferase (AST), > 3x the upper limit ofnormal (ULN), or total bilirubin > 2x ULN before the randomization.
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2(Calculated accordingto the modified MDRD equation).
Severe concomitant non-cardiovascular disease that carries the risk of reducing lifeexpectancy to less than 2 years.
Previous (within 90 days before randomization), current or planned treatment with aPCSK9 monoclonal antibody (mAb).
Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy 2 yearsprior to randomization.
Participation in another investigational device or drug study currently, or within 5half-live (if drug) or 30 days whichever is longer, prior to randomization.
History of hypersensitivity to any study drug or its excipients. 19. Anyuncontrolled or serious disease, or any medical or surgical condition, that mayeither interfere with participation in the clinical study and/or put the participantat significant risk according to investigator's judgment.
Pregnant or nursing (lactating) women. 21. Women of child-bearing potential, unlessthey are using effective methods of contraception during study treatment.
Any conditions that according to the investigator could interfere with the conductof the study.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Harbin, Heilongjiang 150086
ChinaActive - Recruiting
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