PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-85 years old, clinically diagnosed with 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;

LDL-C ≥ 2.6 and < 4.9 mmol/L, or Lp(a) ≥ 30 mg/dL, or receiving statin therapy due to a clinical diagnosis of hypercholesterolemia/hyperlipidemia;

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).

Disqualifiers

Any previous treatment with PCSK9 inhibitors;

Patients must be treated with PCSK9 inhibitors by physician's judgment;

Patients who cannot maintain PCSK9 inhibitor use for 24 months;

Contraindications or hypersensitivity to PCSK9 inhibitors;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with PCSK9 inhibitors

    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

    Other intervention

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Treatment with PCSK9 inhibitorsExperimental treatment 1 intervention
Group B: Treatment without PCSK9 inhibitorsOther 1 intervention

Trial outcomes

Primary outcomes

1

The annualized mean change in peak aortic jet velocity

The peak aortic jet velocity is measured by echocardiography.

Time frame
Up to 24 months

Secondary outcomes

1

The annualized mean change in aortic valve area

The aortic valve area is measured by echocardiography.

Time frame
Up to 24 months
2

The annualized mean change in aortic valve calcium score

The aortic valve calcification score is measured by aortic computed tomography angiography.

Time frame
Up to 24 months
3

Cardiac valve surgery

Transcatheter aortic valve implantation or surgical aortic valve replacement

Time frame
Up to 24 months
4

Change in quality-of-life scores

Change in quality-of-life scores is assessed with the use of the EQ-5D-3L scale

Time frame
Up to 24 months

Other outcomes

1

Safety endpoint

The safety endpoint is a composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke.

Time frame
Up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Beijing Jishuitan Hospital

Collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Beijing Hospital

Collaborator

Nanchong Central Hospital

Collaborator

Peking University First Hospital

Collaborator

Beijing Luhe Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: