A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

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 objective of the study was to evaluate whether PCSK9 inhibitors could delay the progression of aortic stenosis in patients with aortic stenosis.

Secondary objectives: 1) To evaluate whether PCSK9 inhibitors can delay the progression of valve calcification in patients with aortic stenosis;2) To evaluate whether PCSK9 inhibitors can reduce long-term adverse events in patients with aortic stenosis;3) To evaluate the effect of PCSK9 inhibitors on circulating Lp(a) levels in patients with aortic stenosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign informed consent;

Age ≥18 years old, gender unlimited;

Patients with aortic stenosis diagnosed by echocardiography;

Combined with atherosclerotic cardiovascular disease or

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • The Group A received PCSK9 inhibitor plus statin therapy

    Drug

    Subjects randomized to the Group A will be treated with a lipid-lowering regimen based on PCSK9 inhibitors (subcutaneous injection, twice a week) + statins (maximum tolerated dose).

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mean annual variation of peak aortic valve velocity

Mean annual change in peak aortic valve velocity measured by cardiac ultrasound.

Time frame
Baseline ,6 months,12months,24months,36months,48months,

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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