About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign informed consent;
Age ≥18 years old, gender unlimited;
Patients with aortic stenosis diagnosed by echocardiography;
Combined with atherosclerotic cardiovascular disease or
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
The Group A received PCSK9 inhibitor plus statin therapy
DrugSubjects 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).
Treatment groups
Trial outcomes
Primary outcomes
Mean annual variation of peak aortic valve velocity
Mean annual change in peak aortic valve velocity measured by cardiac ultrasound.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: