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Study identifier: NCT04968509 Synced from ClinicalTrials.gov · July 28, 2026
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Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis

Condition: Aortic Stenosis  ·  Sponsor: Beijing Anzhen Hospital

PhasePhase 3
Planned participants160
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease. In fact, aortic valve replacement remains the only treatment option. CAS has been shown to be associated with Lp(a), LDL-C and PCSK9. Several observational studies indicated that the use of statins to decrease LDL-C levels was associated with the reduced incidence of CAS, but no randomized controlled trials (RCTs) showd that statins had any benefit on the progression of CAS. This may be related to the limited reduction of LDL-C by statin therapy. The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have emerged as a new lipid-lowering drug. On the basis of statin therapy, PCSK9 inhibitors can further reduce LDL-C and Lp(a) levels by 50% to 60% and 20% to 30%, respectively. Some studies reported that elevated plasma PCSK9 levels were related to CAS and PCSK9 R46L loss-of-function mutation was associated with lower rates of CAS, and importantly, some observational studies found that PCSK9 inhibitors could reduce the incidence of CAS. Our trial aims to investigate the effect of PCSK9 inhibitors on preventing or delaying the progression of CAS. A total of 160 patients with mild or moderate CAS or asymptomatic severe AS will be randomly assigned to receive either statins or PCSK9 inhibitors+statins. All patients will be followed for at least 2 years at 3, 6,9,12,15,18,21,24 months after random…

This description comes directly from the study's public registry record.

Talk to the study team

Zhijian Wang  ·  +8615711057972  ·  zjwang1975@hotmail.com

Xiaoteng Ma  ·  +8618810616459  ·  maxiaotengai@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Beijing Anzhen Hospital, Capital Medical UniversityBeijing, Beijing Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT04968509