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PCSK9 Inhibitors in the Progression of Aortic Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: PCSK9 Inhibitor [EPC] Drug: Placebos Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Double blind, Multi-center, Randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebos
Patients will receive Placebo by a biweekly injection




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs [ Time Frame: 2 years ]
  2. Mean change in Lp(a) levels between treatment arms [ Time Frame: 2 years ]
    Lp(a) levels will be measured in blood chemistry

  3. Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level [ Time Frame: 2 years ]
    Lipid panels will be measured in blood chemistry

  4. Aortic valve area measured by echocardiography [ Time Frame: 2 years ]
  5. Aortic valve peak velocity measured by echocardiography [ Time Frame: 2 years ]
  6. Any death event [ Time Frame: 2 years ]
  7. Any cardiac death event [ Time Frame: 2 years ]
  8. Any myocardial infarction event [ Time Frame: 2 years ]
  9. Any revascularization for coronary artery disease [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Hyo-Soo Kim, MD, PhD +82-2- 2072-2226 hyosoo@snu.ac.kr
Contact: Jeehoon Kang, MD +82-10-2416-2406 medikang@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Contact: Hyo-Soo Kim, MD, PhD    +82-2- 2072-2226    hyosoo@snu.ac.kr   
Contact: Jeehoon Kang, MD    +82-10-2416-2406    medikang@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Hyo-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03051360    
Other Study ID Numbers: PCSK9 AS
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
aortic valve stenosis
PCSK9 inhibitor
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction