PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis
NCT ID: NCT07256197
Last Updated: 2025-12-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
160 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-01
Study Completion Date
2029-01-31
Brief Summary
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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.
Detailed Description
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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. In fact, aortic valve replacement remains the only treatment option. CAS has been shown to be associated with Lp(a), LDL-C and PCSK9. Several observational studies indicated that the use of statins to decrease LDL-C levels was associated with the reduced incidence of CAS, but no randomized controlled trials (RCTs) showd that statins had any benefit on the progression of CAS. This may be related to the limited reduction of LDL-C by statin therapy. The PCSK9 inhibitors have emerged as a new lipid-lowering drug. On the basis of statin therapy, PCSK9 inhibitors can further reduce LDL-C and Lp(a) levels by 50% to 60% and 20% to 30%, respectively. Some studies reported that elevated plasma PCSK9 levels were related to CAS and PCSK9 R46L loss-of-function mutation was associated with lower rates of CAS, and importantly, some observational studies found that PCSK9 inhibitors could reduce the incidence of CAS. Our trial aims to investigate the effect of PCSK9 inhibitors on preventing or delaying the progression of CAS. A total of 160 patients with mild or moderate CAS not currently requiring valve replacement therapy will be enrolled and randomized (stratified by center) in a 1:1 ratio to two groups, the PCSK9 inhibitor treatment group (test group) or the no PCSK9 inhibitor group (control group). All patients will be followed for at least 2 years after randomization. After enrollment, telephone follow-ups will be conducted in the first month and every three months to collect data including medication use, quality-of-life scores, and clinical endpoint events. Doppler echocardiography will be collected at baseline, the 1-year visit, the 2-year visit, and before study withdrawal. Blood samples and aortic computed tomography angiography (CTA) will be collected at baseline, the 2-year visit, and before study withdrawal. The primary endpoint is the annualized mean change in peak aortic jet velocity over the 24-month follow-up period. Secondary endpoints include the annualized mean change in aortic valve area by echocardiography, the annualized mean change in aortic valve calcium score by aortic CTA, the incidence of cardiac valve surgery, and changes in quality-of-life scores. The safety endpoint is a composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke. The results of this trial will provide new insights into the treatment of CAS patients.
Blood samples should be tested for serological indicators, including blood routine, C-reactive protein (CRP), biochemical, coagulation function, brain natriuretic peptide (BNP), markers of myocardial injury, glycosylated hemoglobin, erythrocyte sedimentation rate, cytokines (12 items).
Blood samples should be tested for serological indicators, including blood routine, C-reactive protein (CRP), biochemical, coagulation function, brain natriuretic peptide (BNP), markers of myocardial injury, glycosylated hemoglobin, erythrocyte sedimentation rate, cytokines (12 items).
Conditions
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Aortic Stenosis, Calcific
Keywords
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PCSK9 Inhibitors
Calcific Aortic Stenosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Treatment with PCSK9 inhibitors
Patients in experimental group are treated with PCSK9 inhibitors (150mg Tafolecimab subcutaneously every two weeks) and guideline-directed management in cardiovascular primary or secondary prevention.
Group Type
EXPERIMENTAL
Treatment with PCSK9 inhibitors
Intervention Type
DRUG
Patients in experimental group are treated with PCSK9 inhibitors (Tafolecimab subcutaneously every two weeks) plus guideline-directed management in cardiovascular primary or secondary prevention.
Treatment without PCSK9 inhibitors
Patients in control group only receive guideline-directed management in cardiovascular primary or secondary prevention without PCSK9 inhibitor treatment.
Group Type
OTHER
Treatment without PCSK9 inhibitors
Intervention Type
OTHER
Patients in control group only receive guideline-directed management in cardiovascular primary or secondary prevention without PCSK9 inhibitor treatment.
Interventions
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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.
Intervention Type
DRUG
Treatment without PCSK9 inhibitors
Patients in control group only receive guideline-directed management in cardiovascular primary or secondary prevention without PCSK9 inhibitor treatment.
Intervention Type
OTHER
Other Intervention Names
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Treatment with Proprotein convertase subtilisin/kexin type 9 inhibitors
Treatment without Proprotein convertase subtilisin/kexin type 9 inhibitors
Eligibility Criteria
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Inclusion Criteria
1. Aged 18-85 years old, clinically diagnosed with simple mild or moderate CAVS (echocardiography shows ejection fraction \> 50%; valve orifice area \> 1.0 cm²; left ventricular stroke volume index \> 35 ml/m²; flow velocity ≥ 2 m/s and \< 4 m/s, or mean transvalvular pressure gradient \< 40 mmHg) and currently not requiring valve replacement therapy;
2. LDL-C ≥ 2.6 and \< 4.9 mmol/L, or Lp(a) ≥ 30 mg/dL;
3. Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo clinical follow-up in accordance with the trial requirements.
* The position and method of measurement have been further clarified in ultrasonic measurement to ensure comparability among all enrolled patients, as follows: Aortic valve peak flow velocity, aortic valve mean pressure gradient, and valve orifice area (select images of at least 3 consecutive cardiac cycles with stable heart rate; for atrial fibrillation, select images of more than 5 consecutive cardiac cycles; obtain the peak blood flow velocity of the aortic valve orifice using continuous wave Doppler in the apical 5-chamber view; calculate the instantaneous aortic valve pressure gradient using the simplified Bernoulli equation, and calculate the standardized aortic valve orifice area using the continuity equation; all participating sonographers will receive unified training, perform measurements in fixed views and retain images, which will then be reviewed by two experienced sonographers who are blinded to the trial in the core laboratory).
2. LDL-C ≥ 2.6 and \< 4.9 mmol/L, or Lp(a) ≥ 30 mg/dL;
3. Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo clinical follow-up in accordance with the trial requirements.
* The position and method of measurement have been further clarified in ultrasonic measurement to ensure comparability among all enrolled patients, as follows: Aortic valve peak flow velocity, aortic valve mean pressure gradient, and valve orifice area (select images of at least 3 consecutive cardiac cycles with stable heart rate; for atrial fibrillation, select images of more than 5 consecutive cardiac cycles; obtain the peak blood flow velocity of the aortic valve orifice using continuous wave Doppler in the apical 5-chamber view; calculate the instantaneous aortic valve pressure gradient using the simplified Bernoulli equation, and calculate the standardized aortic valve orifice area using the continuity equation; all participating sonographers will receive unified training, perform measurements in fixed views and retain images, which will then be reviewed by two experienced sonographers who are blinded to the trial in the core laboratory).
Exclusion Criteria
1. Any previous treatment with PCSK9 inhibitors;
2. Patients must be treated with PCSK9 inhibitors by physician's judgment;
3. Patients who cannot maintain PCSK9 inhibitor use for 24 months;
4. Contraindications or hypersensitivity to PCSK9 inhibitors;
5. Suspected or confirmed familial hypercholesterolemia;
6. Fasting triglycerides (TG) \>400 mg/dL (4.5 mmol/L) at baseline screening;
7. Thyroid hypofunction;
8. Active or chronic liver disease;
9. Severe renal insufficiency (eGFR \<30 mL/min/1.73 m²);
10. History of intracranial hemorrhage;
11. History of alcohol or drug abuse；
12. Known active infection, or severe hematologic, metabolic, or endocrine dysfunction;
13. Systemic corticosteroid or cyclosporine therapy within the past 3 months;
14. Active malignancy;
15. Any life-threatening condition with life expectancy less than 12 months;
16. Rheumatic aortic stenosis;
17. Severe mitral stenosis (mitral valve area \<1 cm²);
18. Severe mitral or aortic regurgitation;
19. Planned cardiac valve surgery;
20. Left ventricular ejection fraction \< 30% or severe heart failure (NYHA class III or IV);
21. Implanted permanent pacemaker or cardioverter-defibrillator;
22. Drug-refractory arrhythmias;
23. Pregnancy, lactation, or planned pregnancy.
2. Patients must be treated with PCSK9 inhibitors by physician's judgment;
3. Patients who cannot maintain PCSK9 inhibitor use for 24 months;
4. Contraindications or hypersensitivity to PCSK9 inhibitors;
5. Suspected or confirmed familial hypercholesterolemia;
6. Fasting triglycerides (TG) \>400 mg/dL (4.5 mmol/L) at baseline screening;
7. Thyroid hypofunction;
8. Active or chronic liver disease;
9. Severe renal insufficiency (eGFR \<30 mL/min/1.73 m²);
10. History of intracranial hemorrhage;
11. History of alcohol or drug abuse；
12. Known active infection, or severe hematologic, metabolic, or endocrine dysfunction;
13. Systemic corticosteroid or cyclosporine therapy within the past 3 months;
14. Active malignancy;
15. Any life-threatening condition with life expectancy less than 12 months;
16. Rheumatic aortic stenosis;
17. Severe mitral stenosis (mitral valve area \<1 cm²);
18. Severe mitral or aortic regurgitation;
19. Planned cardiac valve surgery;
20. Left ventricular ejection fraction \< 30% or severe heart failure (NYHA class III or IV);
21. Implanted permanent pacemaker or cardioverter-defibrillator;
22. Drug-refractory arrhythmias;
23. Pregnancy, lactation, or planned pregnancy.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Beijing Jishuitan Hospital
OTHER
Sponsor Role
collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Sponsor Role
collaborator
Beijing Hospital
OTHER_GOV
Sponsor Role
collaborator
Nanchong Central Hospital
OTHER_GOV
Sponsor Role
collaborator
Peking University First Hospital
OTHER
Sponsor Role
collaborator
Beijing Anzhen Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Zhi Jian Wang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Zhijian Wang
Role: STUDY_CHAIR
Beijing Anzhen Hospital
Xiaoteng Ma
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Site Status
Countries
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China
Central Contacts
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Facility Contacts
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Xiaoteng Ma
Role: primary
References
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Other Identifiers
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PICASO
Identifier Type: -
Identifier Source: org_study_id