Not Yet RecruitingPhase 3

PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis

China160 participantsStarted 2026-04-01

Plain-language summary

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. Our trial aims to investigate the effect of PCSK9 inhibitors on preventing or delaying the progression of CAS.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Aged 18-85 years old, clinically diagnosed with mild or moderate CAVS (echocardiography shows ejection fraction \> 50%; valve orifice area \> 1.0 cm²; left ventricular stroke volume index \> 35 ml/m²; flow velocity ≥ 2 m/s and \< 4 m/s, or mean transvalvular pressure gradient \< 40 mmHg) and currently not requiring valve replacement therapy;
✓. LDL-C ≥ 2.6 and \< 4.9 mmol/L, or Lp(a) ≥ 30 mg/dL, or receiving statin therapy due to a clinical diagnosis of hypercholesterolemia/hyperlipidemia;
✓. Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo clinical follow-up in accordance with the trial requirements.

Exclusion criteria

✕. Any previous treatment with PCSK9 inhibitors;
✕. Patients must be treated with PCSK9 inhibitors by physician's judgment;
✕. Patients who cannot maintain PCSK9 inhibitor use for 24 months;
✕. Contraindications or hypersensitivity to PCSK9 inhibitors;
✕. Suspected or confirmed familial hypercholesterolemia;
✕. Fasting triglycerides (TG) \>400 mg/dL (4.5 mmol/L) at baseline screening;
✕. Thyroid hypofunction;
✕. Active or chronic liver disease;

What they're measuring

The annualized mean change in peak aortic jet velocity

Timeframe: Up to 24 months

Trial details

NCT IDNCT07256197

SponsorBeijing Anzhen Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Zhijian Wang

+8615711057972 zjwang1975@hotmail.com

View on ClinicalTrials.gov More Aortic Stenosis, Calcific trials