PCSK9 Inhibitors in the Progression of Aortic Stenosis
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|ClinicalTrials.gov Identifier: NCT03051360|
Recruitment Status : Unknown
Verified February 2017 by Hyo-Soo Kim, Seoul National University Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Drug: PCSK9 Inhibitor [EPC] Drug: Placebos||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, Double blind, Multi-center, Randomized clinical trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis|
|Estimated Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Active Comparator: PCSK9 inhibitor
Patients will receive bi-weekly PCSK9 inhibitor .
Drug: PCSK9 Inhibitor [EPC]
Patients will receive PCSK9 inhibitor by a biweekly injection
Placebo Comparator: Placebo
Patients will receive bi-weekly placebo.
Patients will receive Placebo by a biweekly injection
- Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET [ Time Frame: 2 years ]Calcium score progression in the PCSK9 inhibitor group and placebo group
- Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs [ Time Frame: 2 years ]
- Mean change in Lp(a) levels between treatment arms [ Time Frame: 2 years ]Lp(a) levels will be measured in blood chemistry
- Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level [ Time Frame: 2 years ]Lipid panels will be measured in blood chemistry
- Aortic valve area measured by echocardiography [ Time Frame: 2 years ]
- Aortic valve peak velocity measured by echocardiography [ Time Frame: 2 years ]
- Any death event [ Time Frame: 2 years ]
- Any cardiac death event [ Time Frame: 2 years ]
- Any myocardial infarction event [ Time Frame: 2 years ]
- Any revascularization for coronary artery disease [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051360
|Contact: Hyo-Soo Kim, MD, PhD||+82-2- firstname.lastname@example.org|
|Contact: Jeehoon Kang, MDemail@example.com|