PCSK9 Inhibitors in the Progression of Aortic Stenosis

NCT03051360 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: PCSK9 AS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

aortic valve stenosis; PCSK9 inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET

  Calcium score progression in the PCSK9 inhibitor group and placebo group

  2 years

Secondary Outcomes (9)

• Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs

  2 years

• Mean change in Lp(a) levels between treatment arms

  2 years

• Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level

  2 years

• Aortic valve area measured by echocardiography

  2 years

• Aortic valve peak velocity measured by echocardiography

  2 years

Study Arms (2)

PCSK9 inhibitor

ACTIVE COMPARATOR

Patients will receive bi-weekly PCSK9 inhibitor .

Drug: PCSK9 Inhibitor [EPC]

Placebo

PLACEBO COMPARATOR

Patients will receive bi-weekly placebo.

Drug: Placebos

Interventions

PCSK9 Inhibitor [EPC] DRUG

Patients will receive PCSK9 inhibitor by a biweekly injection

PCSK9 inhibitor

Placebos DRUG

Patients will receive Placebo by a biweekly injection

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient has a working diagnosis of aortic stenosis (mild to moderate), and has fair treatment compliance.

You may not qualify if:

• Age under 19 years old
• Hypersensitivity to PCSK9 inhibitor
• LDL cholesterol \< 70mg/dL at baseline
• Poor treatement compliance (The patient will need to visit the out-patient clinic every 2-weeks for medication)
• Positive pregnancy test or is known to be pregnant
• 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.)
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

erucylphosphocholine

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Hyo-Soo Kim, MD, PhD

CONTACT

+82-2- 2072-2226; hyosoo@snu.ac.kr

Jeehoon Kang, MD

CONTACT

+82-10-2416-2406; medikang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, Double blind, Multi-center, Randomized clinical trial

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 13, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2020
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

KR (1)