Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-17 @ 9:21 AM
Study NCT ID:
NCT03051360
Status:
UNKNOWN
Last Update Posted:
2017-02-13
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCSK9 Inhibitors in the Progression of Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075010', 'term': 'erucylphosphocholine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Double blind, Multi-center, Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET', 'timeFrame': '2 years', 'description': 'Calcium score progression in the PCSK9 inhibitor group and placebo group'}], 'secondaryOutcomes': [{'measure': 'Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs', 'timeFrame': '2 years'}, {'measure': 'Mean change in Lp(a) levels between treatment arms', 'timeFrame': '2 years', 'description': 'Lp(a) levels will be measured in blood chemistry'}, {'measure': 'Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level', 'timeFrame': '2 years', 'description': 'Lipid panels will be measured in blood chemistry'}, {'measure': 'Aortic valve area measured by echocardiography', 'timeFrame': '2 years'}, {'measure': 'Aortic valve peak velocity measured by echocardiography', 'timeFrame': '2 years'}, {'measure': 'Any death event', 'timeFrame': '2 years'}, {'measure': 'Any cardiac death event', 'timeFrame': '2 years'}, {'measure': 'Any myocardial infarction event', 'timeFrame': '2 years'}, {'measure': 'Any revascularization for coronary artery disease', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic valve stenosis', 'PCSK9 inhibitor'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nFor 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.\n\nRegarding the pathophysiology of AS, an elevation of lipoprotein(a) and dyslipidemia have been reported to be associated with the progression of cardiovascular calcification.\n\nPCSK9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia may be a effective medication to control the progression of AS.\n\nTherefore, investigators will perform a randomized control trial, to compare the effect of PCSK9 inhibitors vs. placebo in its influence to AS progression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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.\n2. The patient has a working diagnosis of aortic stenosis (mild to moderate), and has fair treatment compliance.\n\nExclusion Criteria:\n\n1. Age under 19 years old\n2. Hypersensitivity to PCSK9 inhibitor\n3. LDL cholesterol \\< 70mg/dL at baseline\n4. Poor treatement compliance (The patient will need to visit the out-patient clinic every 2-weeks for medication)\n5. Positive pregnancy test or is known to be pregnant\n6. 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.)\n7. 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"}, 'identificationModule': {'nctId': 'NCT03051360', 'briefTitle': 'PCSK9 Inhibitors in the Progression of Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis', 'orgStudyIdInfo': {'id': 'PCSK9 AS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCSK9 inhibitor', 'description': 'Patients will receive bi-weekly PCSK9 inhibitor .', 'interventionNames': ['Drug: PCSK9 Inhibitor [EPC]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive bi-weekly placebo.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'PCSK9 Inhibitor [EPC]', 'type': 'DRUG', 'description': 'Patients will receive PCSK9 inhibitor by a biweekly injection', 'armGroupLabels': ['PCSK9 inhibitor']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Patients will receive Placebo by a biweekly injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '+82-2- 2072-2226'}, {'name': 'Jeehoon Kang, MD', 'role': 'CONTACT', 'email': 'medikang@gmail.com', 'phone': '+82-10-2416-2406'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '+82-2- 2072-2226'}, {'name': 'Jeehoon Kang, MD', 'role': 'CONTACT', 'email': 'medikang@gmail.com', 'phone': '+82-10-2416-2406'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}