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PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis

NCT07256197 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-02

No results posted yet for this study

Summary

Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease. Our trial aims to investigate the effect of PCSK9 inhibitors on preventing or delaying the progression of CAS.

Conditions

  • Aortic Stenosis, Calcific

Interventions

DRUG

Treatment with PCSK9 inhibitors

Patients in experimental group are treated with PCSK9 inhibitors (Tafolecimab subcutaneously every two weeks) plus guideline-directed management in cardiovascular primary or secondary prevention.

OTHER

Treatment without PCSK9 inhibitors

Patients in control group only receive guideline-directed management in cardiovascular primary or secondary prevention without PCSK9 inhibitor treatment.

Sponsors & Collaborators

  • Beijing Jishuitan Hospital

    collaborator OTHER

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Nanchong Central Hospital

    collaborator OTHER_GOV

  • Peking University First Hospital

    collaborator OTHER

  • Beijing Luhe Hospital

    collaborator OTHER

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Zhijian Wang · Beijing Anzhen Hospital

  • Xiaoteng Ma · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07256197 on ClinicalTrials.gov