Clinical trial NCT06996223: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
Official title: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Aortic Stenosis
PCSK9 Inhibitor
Calcified Aortic Valve Disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized to the experimental group will be treated with a lipid-lowering regimen based on PCSK9 inhibitors (subcutaneous injection, twice a week) + statins (maximum tolerated dose).

Subjects randomized to the control group will be treated with a lipid-lowering regimen based on statins (the maximum tolerated dose).

The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests.
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Mean annual variation of peak aortic valve velocity
timeFrame: Baseline ,6 months,12months,24months,36months,48months,
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: