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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean annual variation of peak aortic valve velocity | Mean annual change in peak aortic valve velocity measured by cardiac ultrasound. | Baseline ,6 months,12months,24months,36months,48months, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qingchunzeng zeng Doctoral candidate, chief physician, postdoctoral supervisor | Contact | +86 15815838368 | qingchunzeng@smu.edu.cn |
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all collected IPD, all IPD that underlie results in a publication
June 2025 - June 2029
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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.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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