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A multi-center, prospective, randomized controlled trial to evaluate the efficacy of PCSK-9 inhibitors in delaying the progression of calcified aortic valve disease

A multi-center, prospective, randomized controlled trial to evaluate the efficacy of PCSK-9 inhibitors in delaying the progression of calcified aortic valve disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102781
Enrollment
Unknown
Registered
2025-05-20
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Interventions

Test group:PCSK9 inhibitor (subcutaneous injection, once every 2 weeks) plus statin (maximum tolerated dose) therapy
Control group:statin (maximum tolerated dose) therapy

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign informed consent; 2. Age > 18 years old, gender is not limited; 3. Patients with aortic stenosis diagnosed by echocardiography; 4. Combined with atherosclerotic cardiovascular disease or hypercholesterolemia LDL-C >=4.9mmol/L; 5. Blood lipids are not up to standard after maximum tolerated dose of statins;

Exclusion criteria

Exclusion criteria: 1. Rheumatic aortic stenosis; 2. Previous use of PCSK9 inhibitors or allergy to PCSK9 inhibitors; 3. Left ventricular ejection fraction <=35%; 4. Patients who plan to undergo aortic valve replacement or TAVR in the near future; 5. Complicated with other severe valvular diseases; 6. Treatment adherence was poor and medication was not administered according to the trial protocol; 7. Pregnant and lactating women; 8. Combined with active malignant tumor, severe liver and kidney dysfunction and other life expectancy of less than 1 year; 9. Participants who are participating in other interventional clinical studies; 10. Patients who were judged by the investigator to be ineligible for participation in the trial;

Design outcomes

Primary

MeasureTime frame
Peak aortic valve velocity;

Secondary

MeasureTime frame
Major adverse cardiac events;Aortic valve area;Adverse aortic events, AAE;Major adverse cardiac events, MACE;

Countries

China

Contacts

Public ContactZeng Qingchun

Southern Medical University Southern Hospital

qingchunzeng@smu.edu.cn+86 15815838368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026