Aortic Valve StenosisPhase 2NCT03051360
PCSK9 Inhibitors in the Progression of Aortic Stenosis
A Phase 2 study testing PCSK9 Inhibitor [EPC] in people with Aortic Valve Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- PCSK9 Inhibitor [EPC]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 1 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul
Hyo-Soo Kim, MD, PhD, +82-2- 2072-2226, hyosoo@snu.ac.kr
Jeehoon Kang, MD, +82-10-2416-2406, medikang@gmail.com
About this study
Official title: Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- PCSK9 Inhibitor [EPC], Placebos
- Keywords
- aortic valve stenosis, PCSK9 inhibitor
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 Inhibitor [EPC]Drug
Patients will receive PCSK9 inhibitor by a biweekly injection
PlacebosDrug
Patients will receive Placebo by a biweekly injection
| Study group | Role | What they receive |
|---|---|---|
| PCSK9 inhibitor | Active comparator | Patients will receive bi-weekly PCSK9 inhibitor . Receives: Drug: PCSK9 Inhibitor [EPC] |
| Placebo | Placebo comparator | Patients will receive bi-weekly placebo. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (9)
Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs
Measured: 2 years
Mean change in Lp(a) levels between treatment arms
Lp(a) levels will be measured in blood chemistry
Measured: 2 years
Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level
Lipid panels will be measured in blood chemistry
Measured: 2 years
Aortic valve area measured by echocardiography
Measured: 2 years
Aortic valve peak velocity measured by echocardiography
Measured: 2 years
Any death event
Measured: 2 years
Any cardiac death event
Measured: 2 years
Any myocardial infarction event
Measured: 2 years
Any revascularization for coronary artery disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Double blind, Multi-center, Randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051360
- Sponsor's protocol ID
- PCSK9 AS
- Status last verified
- Feb 2017
- First submitted
- 23 Jan 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03051360
- Acronym / sponsor ID
- PCSK9 AS
- Conditions
- Aortic Valve Stenosis
- Keywords
- aortic valve stenosis, PCSK9 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Double blind, Multi-center, Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| PCSK9 inhibitor | Active comparator | Drug: PCSK9 Inhibitor [EPC]Patients will receive bi-weekly PCSK9 inhibitor . |
| Placebo | Placebo comparator | Drug: PlacebosPatients will receive bi-weekly placebo. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCSK9 Inhibitor [EPC]Patients will receive PCSK9 inhibitor by a biweekly injection | Drug | PCSK9 inhibitor |
| PlacebosPatients will receive Placebo by a biweekly injection | Drug | Placebo |
Primary outcome
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
9 secondary outcomes
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
Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level
Time frame: 2 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCSK9 Inhibitor [EPC] in people with Aortic Valve Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-Soo Kim, MD, PhD (+82-2- 2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.