Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-01 @ 7:08 PM
Study NCT ID:
NCT04499859
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3548}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events (MACE)', 'timeFrame': '24 months', 'description': 'A composite of cardiovascular death, major coronary events (non-fatal MI, documented unstable angina requiring hospital admission, all coronary revascularization with either PCI or bypass surgery occurring at least 30 days after randomization), or non-fatal stroke.'}], 'secondaryOutcomes': [{'measure': 'death from any cause, a major coronary event, or a non-fatal stroke', 'timeFrame': '24 months', 'description': 'death from any cause, a major coronary event, or a non-fatal stroke'}, {'measure': 'cardiovascular death, non-fatal MI, or non-fatal stroke', 'timeFrame': '24 months', 'description': 'cardiovascular death, non-fatal MI, or non-fatal stroke'}, {'measure': 'all-cause death from any cause', 'timeFrame': '24months'}, {'measure': 'cardiovascular death', 'timeFrame': '24months'}, {'measure': 'any myocardial infaction', 'timeFrame': '24 months'}, {'measure': 'any stroke', 'timeFrame': '24 months'}, {'measure': 'any revascularization occurring at least 30 days after randomization', 'timeFrame': '24 months'}, {'measure': 'LDL-C reduction <= 70mg/dl', 'timeFrame': '3 months', 'description': 'LDL cholesterol level of 70mg/dL or less'}, {'measure': 'LDL-C reduction <= 55mg/dl', 'timeFrame': '3 months'}, {'measure': 'Rate of Statin associated muscle symptoms', 'timeFrame': '3 months', 'description': 'Stain Associated Muscle Symptom questionnaire'}, {'measure': 'drug discontinuation or dose reduction', 'timeFrame': '24 months'}, {'measure': 'pill count drug adherence', 'timeFrame': '24 months'}, {'measure': 'new onset diabetes', 'timeFrame': '24 months'}, {'measure': 'cataract', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Statin Adverse Reaction', 'HMG-CoA Reductase Inhibitor Toxicity']}, 'referencesModule': {'references': [{'pmid': '41198200', 'type': 'DERIVED', 'citation': 'Choo EH, Kim CJ, Hwang BH, Lee KY, Oh GC, Lim S, Choi IJ, Kim DB, Kwon OS, Lee S, Choi Y, Park CS, Park MW, Kim HY, Lee HC, Kang TS, Sung JK, Woo SI, Park HS, Yun KH, Chang K; ROSUZET-AMI investigator. High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial. BMJ Open. 2025 Nov 5;15(11):e104127. doi: 10.1136/bmjopen-2025-104127.'}]}, 'descriptionModule': {'briefSummary': 'Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.\n\nThis trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.', 'detailedDescription': 'IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults Aged 19 and up\n2. Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)\n3. For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test\n4. Patients who agreed and signed on the informed consent form\n\nExclusion Criteria:\n\n1. Patients with life expectancy of a year or less due to malignancy\n2. Patients with chronic liver disease\n3. Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.\n4. Pregnant and/or breastfeeding\n5. Female patients who are unable to use any means of contraception\n6. Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease\n7. Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)\n8. Patients considered inappropriate for the study for any other reason(s) by the inspector(s)'}, 'identificationModule': {'nctId': 'NCT04499859', 'acronym': 'ROSUZET-AMI', 'briefTitle': 'Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'ROSUZET-AMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ezetimibe 10 mg plus rosuvastatin 5 mg', 'description': 'Rosuzet 5/10 mg , once a day for 24 months', 'interventionNames': ['Drug: Ezetimibe 10mg + Rosuvastatin 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rosuvastatin 20 mg only', 'description': 'Any brand drugs of rosuvastatin 20mg, once a day for 24 months', 'interventionNames': ['Drug: Rosuvastatin 20mg']}], 'interventions': [{'name': 'Ezetimibe 10mg + Rosuvastatin 5mg', 'type': 'DRUG', 'otherNames': ['Rosuzet 10/5 mg'], 'description': 'Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin', 'armGroupLabels': ['ezetimibe 10 mg plus rosuvastatin 5 mg']}, {'name': 'Rosuvastatin 20mg', 'type': 'DRUG', 'otherNames': ['Crestor 20mg'], 'description': '20mg of Rosuvastatin as a standard treatment for AMI patients', 'armGroupLabels': ['rosuvastatin 20 mg only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hee Yeol Kim, M.D.', 'role': 'CONTACT'}], 'facility': 'Bucheon St.Mary Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Suwon', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki-Dong Yoo, M.D.', 'role': 'CONTACT'}], 'facility': "St.Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Uijeongbu-si', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chan Joon Kim, M.D.', 'role': 'CONTACT'}], 'facility': "Uijeongbu St.Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Man Won Park, M.D.', 'role': 'CONTACT'}], 'facility': "Daejeon St.Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Doo Soo Jeon, M.D.', 'role': 'CONTACT'}], 'facility': "Incheon St.Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '137-701', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kiyuk Chang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seoul St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chul-Soo Park, M.D.', 'role': 'CONTACT'}], 'facility': 'Yeouido St.Mary Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kiyuk Chang, MD,PhD', 'role': 'CONTACT', 'email': 'kiyuk@catholic.ac.kr', 'phone': '82-10-9175-2076'}, {'name': 'Eun Ho Choo, MD', 'role': 'CONTACT', 'email': 'cmcchu@catholic.ac.kr', 'phone': '82-10-8500-4569'}], 'overallOfficials': [{'name': 'Kiyuk Chang, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate summary data available on reasonable request. Exceptionally, and subject to Steering Committee approval, deidentified core analytic IPD may be accessed in a secure, non-downloadable virtual environment at the coordinating center. Contact PI (Kiyuk Chang) with proposal + ethics documentation; DUA required; costs may apply.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kiyuk Chang, MD,PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kiyuk Chang, MD,PhD', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}