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).
This study will be a multi-center, randomized, parallel-group, open-label, phase 4 study. Participants will be Chinese adults diagnosed with new-onset STEMI/NSTEMI and elevated LDL-C (LDL-C \> 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks; LDL-C \> 2.6 mmol/L if not on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks). Participants will be 1:1 randomized to investigational group (Inclisiran 284mg + 20mg atorvastatin) or control group (20mg atorvastatin) for 360 days. Participants and investigator will be unblinded to the identity of the treatment from the time of randomization. Independent Review Committee (IRC) staff performing the study assessments (IVUS and OCT analysis) will be blinded to the identity of the treatment from the time of randomization until final database lock.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
318
20mg atorvastatin PO
performed the IVUS/OCT at baseline and Day 360
Inclisiran 284mg SC
Novartis Investigative Site
Hefei, Anhui, China
Novartis Investigative Site
Fuzhou, Fujian, China
Change in percent atheroma volume (PAV)
Change in PAV assessed by intravascular ultrasound (IVUS) from baseline to Day 360.
Time frame: Up to 360 days
Change in minimum fibrous cap thickness (FCT)
Change in minimum FCT as determined by optical coherence tomography (OCT) from baseline to Day 360
Time frame: Up to 360 days
Change in mean minimum FCT of all images
Change in mean minimum fibrous cap thickness (FCT) of all images as determined by OCT from baseline to Day 360.
Time frame: 360 days
Change in normalized total atheroma volume (NTAV)
Change in NTAV as determined by intravascular ultrasound (IVUS) from baseline to Day 360
Time frame: Up to 360 days
Proportion of participants with progression, regression, or no change in PAV
Proportion of participants with progression, regression, or no change in percent atheroma volume (PAV) at Day 360
Time frame: Up to 360 days
Change in LDL-C
Change in low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in TC
Change in total cholesterol (TC).
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in HDL-C
Change in high-density lipoprotein cholesterol (HDL-C).
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Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shenzhen, Guangdong, China
Novartis Investigative Site
Zunyi, Guizhou, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Nanchang, Jiangxi, China
...and 9 more locations
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in non-HDL-C
Change in non-high-density lipoprotein cholesterol (non-HDL-C).
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in ApoB
Change in apolipoprotein B (ApoB).
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in ApoA1
Change in apolipoprotein A1 (ApoA1).
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in Lp(a)
Change in lipoprotein (a) (Lp(a))
Time frame: Baseline, Day 30, Day 150 and Day 360
Change in TG
Change in triglycerides (TG)
Time frame: Baseline, Day 30, Day 150 and Day 360
Proportion of participants with LDL-C target attainment
Proportion of participants with LDL-C target attainment at Day 30, Day 150, and Day 360
Time frame: Day 30, Day 150 and Day 360