Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT02232360
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-12', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions', 'timeFrame': 'After 12±2 months treatment', 'description': 'Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS'}], 'secondaryOutcomes': [{'measure': 'Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions', 'timeFrame': 'After 12±2 months treatment', 'description': 'Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS'}, {'measure': 'Presence of thin-cap fibroatheroma', 'timeFrame': 'After 12±2 months treatment', 'description': 'change of plaque phenotype by VH-IVUS'}, {'measure': 'Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume', 'timeFrame': 'After 12±2 months treatment', 'description': 'Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS'}, {'measure': 'Remodeling index', 'timeFrame': 'After 12±2 months treatment', 'description': 'Remodeling index by VH-IVUS'}, {'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': 'After 12 months treatment', 'description': 'The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization'}, {'measure': 'Adverse drug events', 'timeFrame': 'After 12±2 months treatment', 'description': 'Adverse drug events related by study drugs'}, {'measure': 'Creatine phosphokinase', 'timeFrame': 'After 12±2 months treatment', 'description': 'measurement of muscular side effects related by study drugs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atherosclerotic plaque', 'Virtual histology intravascular ultrasound', 'Plaque composition', 'Rosuvastatin', 'Fenofibrate', 'Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '32321551', 'type': 'DERIVED', 'citation': 'Kwon TG, Jang AY, Kim SW, Hong YJ, Bae JH, Lee SY, Kim SH, Han SH. Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study. Trials. 2020 Apr 22;21(1):353. doi: 10.1186/s13063-020-04291-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effects of combination therapy with rosuvastatin and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary lesions with intermediate stenosis in patient with coronary artery disease, compared with rosuvastatin alone therapy.', 'detailedDescription': 'Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. In the past few decades, optimal pharmacological therapies with statins targeting LDL-cholesterol substantially reduce the risks of cardiovascular disease. However, the residual cardiovascular risk is still high, requiring need for additional preventive therapies to achieve even greater risk reduction.\n\nRecent meta-analysis demonstrated fibrates can reduce the risk of coronary events and might have a role in patients with high cardiovascular risks or combined dyslipidemia. Likewise, fenofibrate had a possible benefit for patients with high triglyceride level and low HDL-cholesterol level in the post-hoc analysis of ACCORD or FIELD trials.\n\nThus, investigators tried to determine effects of combination therapy with rosuvastatin and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary lesions with intermediate stenosis in patient with coronary artery disease, compared with rosuvastatin alone therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery disease who were 20 years of age or older and needed coronary angiography\n* Intermediate coronary artery stenosis (diameter stenosis ≥30% to ≤60% by visual estimation, diameter ≥2.0 mm to ≤4.0 mm, de novo lesion in native coronary artery) in which virtual histology-intravascular ultrasound (VH-IVUS) could be feasible\n* Combined dyslipidemia\n\n * Stain-naive patients - LDL-cholesterol ≥70 mg/dL and non-HDL-cholesterol ≥130 mg/dL\n * Patients taking statin within 2 weeks - LDL-cholesterol \\< 100 mg/dL and non-HDL-cholesterol ≥100 mg/dL\n* Patients who gave written informed consent\n\nExclusion Criteria:\n\n* Diabetic patients\n* Cardiogenic shock\n* Heart failure with symptoms of New York Heart Association class III/IV or left ventricular ejection fraction \\<35%\n* Renal dysfunction (creatinine level ≥1.7 mg/dL or dependence of dialysis\n* Hepatic dysfunction (transaminase level \\> 3 times of normal within limit)\n* Pregnancy or breast-feeding women\n* Familial hypercholesterolemia\n* Hypertriglyceridemia (triglyceride level \\>500 mg/dL)'}, 'identificationModule': {'nctId': 'NCT02232360', 'briefTitle': 'Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial)', 'orgStudyIdInfo': {'id': 'STAFENO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin and fenofibrate', 'description': 'Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day', 'interventionNames': ['Drug: Rosuvastatin and fenofibrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin alone', 'description': 'Rosuvastatin 10 mg per day', 'interventionNames': ['Drug: Rosuvastatin alone']}], 'interventions': [{'name': 'Rosuvastatin and fenofibrate', 'type': 'DRUG', 'otherNames': ['Combination therapy with rosuvastatin and fenofibrate'], 'description': 'Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day', 'armGroupLabels': ['Rosuvastatin and fenofibrate']}, {'name': 'Rosuvastatin alone', 'type': 'DRUG', 'otherNames': ['Rosuvastatin alone therapy'], 'description': 'Rosuvastatin 10mg per day', 'armGroupLabels': ['Rosuvastatin alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jang Ho Bae, MD', 'role': 'CONTACT'}, {'name': 'Jang Ho Bae, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Joon Hong, MD', 'role': 'CONTACT'}, {'name': 'Young-Joon Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonnam National University Medical School and Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Ilsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Yoon Lee, MD', 'role': 'CONTACT'}, {'name': 'Sung Yoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University ilsanPaik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'zip': '405-760', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Hwan Han, MD, PhD', 'role': 'CONTACT', 'email': 'shhan@gilhospital.com', 'phone': '82-32-460-3054'}, {'name': 'Seung Hwan Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Wook Kim, MD', 'role': 'CONTACT'}, {'name': 'Sang-Wook Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Hyun Kim, MD', 'role': 'CONTACT'}, {'name': 'Sang Hyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National Univesity Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung Hwan Han, MD', 'role': 'CONTACT', 'email': 'shhan@gilhospital.com', 'phone': '82-32-460-3054'}, {'name': 'Pyung Chun Oh, MD', 'role': 'CONTACT', 'email': 'likemed@gilhospital.com', 'phone': '82-32-460-3054'}], 'overallOfficials': [{'name': 'Seung Hwan Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seung Hwan Han', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}