Brief Title
PCSK9 Inhibitors in the Progression of Aortic Stenosis
Official Title
Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis
Brief Summary
Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower
lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis,
through a randomized controlled trial.
Detailed Description
Aortic valve disease is the most common form of heart valve disease and is a major burden to
society. Aortic valve disease is also expected to become more prevalent with the aging. Among
aortic diseases, 'aortic stenosis (AS)', which is a narrowing of the aortic valve, and leads
to symptoms of heart failure and sometimes death.
For treatment of AS, the valve in replaced in a surgical to percutaneous method. Regardless
of the method, valve replacement has its potential costs and complications that is an
important issue that needs to be solved. Therefore, controlling the progression of AS and
increasing the efficacy of medical therapy before valvular replacement is needed, is an
important medico-social problem.
Regarding the pathophysiology of AS, an elevation of lipoprotein(a) and dyslipidemia have
been reported to be associated with the progression of cardiovascular calcification.
PCSK9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia
may be a effective medication to control the progression of AS.
Therefore, investigators will perform a randomized control trial, to compare the effect of
PCSK9 inhibitors vs. placebo in its influence to AS progression.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET
Secondary Outcome
Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs
Condition
Aortic Valve Stenosis
Intervention
PCSK9 Inhibitor [EPC]
Study Arms / Comparison Groups
PCSK9 inhibitor
Description: Patients will receive bi-weekly PCSK9 inhibitor .
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
140
Start Date
June 1, 2017
Completion Date
January 1, 2020
Primary Completion Date
December 31, 2019
Eligibility Criteria
Inclusion Criteria:
1. The patient agrees to participate in this study by signing the informed consent form.
Alternatively, a legally authorized patient representative may agree to the patient's
participation in this study and sign the informed consent form.
2. The patient has a working diagnosis of aortic stenosis (mild to moderate), and has
fair treatment compliance.
Exclusion Criteria:
1. Age under 19 years old
2. Hypersensitivity to PCSK9 inhibitor
3. LDL cholesterol < 70mg/dL at baseline
4. Poor treatement compliance (The patient will need to visit the out-patient clinic
every 2-weeks for medication)
5. Positive pregnancy test or is known to be pregnant
6. Any other reason the investigator deems the subject to be unsuitable for the study
(e.g., Active malignant tumor, Any life-threatening condition with life expectancy
less than 6months, etc.)
7. Any clinically significant abnormality identified at the screening visit, physical
examination, laboratory tests, or electrocardiogram which, in the judgment of the
investigator, would preclude safe completion of the study
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +82-2- 2072-2226, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03051360
Organization ID
PCSK9 AS
Responsible Party
Principal Investigator
Study Sponsor
Seoul National University Hospital
Study Sponsor
, ,
Verification Date
February 2017