Aortic StenosisEarly Phase 1NCT06996223
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
A Early Phase 1 study testing The Group A received PCSK9 inhibitor plus statin therapy in people with Aortic Stenosis and PCSK9 Inhibitor, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, PCSK9 Inhibitor, Calcified Aortic Valve Disease
- What is being tested?
- The Group A received PCSK9 inhibitor plus statin therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
qingchunzeng zeng Doctoral candidate, chief physician, postdoctoral supervisor contact
About this study
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.
- Being tested
- The Group A received PCSK9 inhibitor plus statin therapy
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Group A received PCSK9 inhibitor plus statin therapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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).
The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests. Receives: Drug: The Group A received PCSK9 inhibitor plus statin therapy |
| Group B | No intervention | Subjects randomized to the B group will be treated with a lipid-lowering regimen based on statins (the maximum tolerated dose). The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean annual variation of peak aortic valve velocity
Mean annual change in peak aortic valve velocity measured by cardiac ultrasound.
Measured: Baseline ,6 months,12months,24months,36months,48months,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized to the experimental group will be treated with a lipid-lowering regimen based on PCSK9 inhibitors (subcutaneous injection, twice a week) + statins (maximum tolerated dose). Subjects randomized to the control group will be treated with a lipid-lowering regimen based on statins (the maximum tolerated dose). The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996223
- Sponsor's protocol ID
- NFEC-2025-177
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT06996223
- Acronym / sponsor ID
- NFEC-2025-177
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects randomized to the experimental group will be treated with a lipid-lowering regimen based on PCSK9 inhibitors (subcutaneous injection, twice a week) + statins (maximum tolerated dose). Subjects randomized to the control group will be treated with a lipid-lowering regimen based on statins (the maximum tolerated dose). The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: The Group A received PCSK9 inhibitor plus statin therapySubjects 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). The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests. |
| Group B | No intervention | –Subjects randomized to the B group will be treated with a lipid-lowering regimen based on statins (the maximum tolerated dose). The study lasted for 4 years, and the patients were followed up at 1, 6, 12, 24, 36, and 48 months to assess the efficacy and safety of the drug administration and to collect information on relevant examinations and tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Group A received PCSK9 inhibitor plus statin therapySubjects 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). | Drug | Group A |
Primary outcome
Mean annual variation of peak aortic valve velocity
Time frame: Baseline ,6 months,12months,24months,36months,48months,
Mean annual change in peak aortic valve velocity measured by cardiac ultrasound.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
qingchunzeng zeng Doctoral candidate, chief physician, postdoctoral supervisor contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing The Group A received PCSK9 inhibitor plus statin therapy in people with Aortic Stenosis and PCSK9 Inhibitor, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qingchunzeng zeng Doctoral candidate, chief physician, postdoctoral supervisor (+86 15815838368, qingchunzeng@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean annual variation of peak aortic valve velocity (time frame: Baseline ,6 months,12months,24months,36months,48months,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.