Status:
NOT_YET_RECRUITING
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Aortic Stenosis
PCSK9 Inhibitor
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 object...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT06996223
Start Date
June 1 2025
End Date
December 30 2027
Last Update
May 30 2025
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