A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease

The aim of this clinical trial is to understand whether the drug PCSK9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug.

The primary objective of the study was to evaluate whether PCSK9 inhibitors could delay the progression of aortic stenosis in patients with aortic stenosis.

Secondary objectives: 1) To evaluate whether PCSK9 inhibitors can delay the progression of valve calcification in patients with aortic stenosis;2) To evaluate whether PCSK9 inhibitors can reduce long-term adverse events in patients with aortic stenosis;3) To evaluate the effect of PCSK9 inhibitors on circulating Lp(a) levels in patients with aortic stenosis.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Calcified Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases PCSK9 Inhibitor Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Voluntarily sign informed consent;
Age ≥18 years old, gender unlimited;
Patients with aortic stenosis diagnosed by echocardiography;
Combined with atherosclerotic cardiovascular disease or
hypercholesterolemia LDL-C≥4.9mmol/L;
The blood lipids were not up to standard after the maximum tolerated dose of statins;

Exclusion criteria

Rheumatic aortic stenosis;
Previous use of PCSK9 inhibitors or allergy to PCSK9 inhibitors;
Left ventricular ejection fraction ≤35%;
Patients planned to undergo aortic valve replacement or TAVR in the near future;
Complicated with other severe valvular diseases;
Poor adherence to treatment and inability to take medication according to the trial protocol;
Pregnant and lactating women;
Combined with active malignant tumors, severe liver and kidney dysfunction and other life expectancy of less than 1 year;
Participants who are participating in other interventional clinical studies;
Patients who were judged by the investigator to be ineligible for participation in the trial

Treatment and study plan

The Group A received PCSK9 inhibitor plus statin therapy

Drug

Subjects randomized to the Group A will be treated with a lipid-lowering regimen based on PCSK9 inhibitors (subcutaneous injection, twice a week) + statins (maximum tolerated dose).

Primary outcomes

Mean annual variation of peak aortic valve velocity

Time frame: Baseline ,6 months,12months,24months,36months,48months,

Mean annual change in peak aortic valve velocity measured by cardiac ultrasound.

Study contacts

Contact information is provided by the study sponsor or research team.

qingchunzeng zeng Doctoral candidate, chief physician, postdoctoral supervisor

CONTACT

[email protected]

+86 15815838368

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 30, 2025
Registry last updated: May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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