A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibi… (NCT06996223) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
316 participantsStarted 2025-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily sign informed consent;
* Age ≥18 years old, gender unlimited;
* Patients with aortic stenosis diagnosed by echocardiography;
* Combined with atherosclerotic cardiovascular disease or
* hypercholesterolemia LDL-C≥4.9mmol/L;
* The blood lipids were not up to standard after the maximum tolerated dose of statins;
Exclusion Criteria:
* 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;
* Complicated with other severe valvular diseases;
* Poor adherence to treatment and inability to take medication according to the trial protocol;
* Pregnant and lactating women;
* Combined with active malignant tumors, severe liver and kidney dysfunction and other life expectancy of less than 1 year;
* Participants who are participating in other interventional clinical studies;
* Patients who were judged by the investigator to be ineligible for participation in the trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean annual variation of peak aortic valve velocity