Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT05884502
Status:
UNKNOWN
Last Update Posted:
2023-06-01
First Post:
2023-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Study to Evaluate the Effect of High Dose Rosuvastatin Versus Rosuvastatin and Ezetimibe in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], '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': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter prospective randomized-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of reaching target LDL-C (low-density lipoprotein cholesterol) levels', 'timeFrame': '90 days after enrollment', 'description': 'LDL-C (low-density lipoprotein cholesterol) \\< 70 mg/dL or 50% or more decrease from baseline'}, {'measure': 'Changes in total cholesterol, HDL-C (high-density lipoprotein cholesterol), and TG (Triglyceride) levels at 3 months compared to randomization', 'timeFrame': '90 days after enrollment', 'description': 'Changes in total cholesterol, HDL-C (high-density lipoprotein cholesterol), and TG (Triglyceride) levels at 90 days'}, {'measure': 'Clinical event occurence- major cardiovascular adverse event (MACE)', 'timeFrame': '90 days after enrollment', 'description': 'MACE; relapse of stroke, cardiovascular death, other death, occurrence of coronary artery disease, occurrence of myocardial infarction requiring percutaneous coronary intervention'}, {'measure': 'Clinical Stroke Scale', 'timeFrame': '90 days after enrollment', 'description': 'NIHSS (National Institute of Health stroke scale) score,'}, {'measure': 'Clinical Stroke Scale', 'timeFrame': '90 days after enrollment', 'description': 'mRS (modified Rankins scale) score'}, {'measure': 'Safety endpoints', 'timeFrame': '90 days after enrollment', 'description': 'newly diagnosed diabetes mellitus'}, {'measure': 'Safety endpoints', 'timeFrame': '90 days after enrollment', 'description': 'newly developed muscle symptoms measured with statin related muscle symptoms questionnaire (SAMS-Q)'}, {'measure': 'Safety endpoints', 'timeFrame': '90 days after enrollment', 'description': 'liver enzyme levels (AST in IU/L, ALT in IU/L)'}, {'measure': 'Safety endpoints', 'timeFrame': '90 days after enrollment', 'description': 'development of intracranial hemorrhage'}], 'primaryOutcomes': [{'measure': 'Absolute value of LDL-C (low-density lipoprotein cholesterol) reduction', 'timeFrame': '90 days after enrollment', 'description': 'low-density lipoprotein cholesterol reduction at 90 days after enrollment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Stroke, Acute Ischemic']}, 'descriptionModule': {'briefSummary': 'High-intensity statins are recommended for secondary prevention of stroke in patients with atherosclerotic ischemic stroke. According to the guidelines of the American Heart Association and the American Stroke Society, high-intensity or high-dose statins are recommended for high-risk groups of atherosclerotic cardiovascular disease (ASCVD). Statin therapy is recommended even if it is less than 100 mg/dL. The 2016 ESC/EAS and 2017 AACE guidelines include ischemic stroke and transient cerebral ischemic attacks caused by atherosclerosis in ASCVD, classifying them as ultra-high-risk groups, and recommending LDL cholesterol of less than 70 mg/dL as a treatment goal. The recently published guidelines for dyslipidemia in Korea also recommend that the target level of LDL cholesterol in patients with atherosclerotic ischemic stroke and transient ischemic attack be reduced to less than 70 mg/dL or 50% or more from the baseline.\n\nAccording to a previous study on the efficacy and safety of high-intensity rosuvastatin in patients with ischemic stroke, it is not clear whether the use of rosuvastatin 20 mg prevents recurrence of cerebral infarction in the acute stage, but it is safe and effective for hemorrhagic conversion of cerebral infarction. In addition, the results were shown when rosuvastatin and ezetimibe were combined in patients with high cardiovascular risk, LDL cholesterol and total cholesterol decreased more in the combined group than in the single agent group. In a study comparing the group whose LDL cholesterol target was reduced to 70 mg/dL or less after stroke and the group maintained at 90-110 mg/dL, the group whose LDL cholesterol was controlled to 70 mg/dL or less It was confirmed that the incidence of cardiovascular disease was reduced. Existing studies aimed at general high-risk groups, not specific disease groups, and as in this study, studies were not conducted on a single disease group called acute stroke. In addition, there are only limited studies on the effectiveness and safety of diseases that occur mainly in the elderly, such as acute stroke. Therefore, there are currently no studies on the clinical efficacy and safety of high-intensity rosuvastatin and ezetimibe combination therapy for patients with acute cerebral infarction.', 'detailedDescription': 'Multicenter, randomized controlled trial to compare the efficacy and safety of the test group (high-dose rosuvastatin and ezetimibe combined administration group) and control group (high-dose rosuvastatin single administration group) to achieve the target LDL-C level in patients who have recently experienced an ischemic stroke; It is an open-label, investigator-led clinical trial.\n\nIn this clinical trial, treatment is performed according to the general treatment procedure for patients who have recently had an ischemic stroke. Subjects who agree to participate in the clinical trial and satisfy the selection and exclusion criteria are the test group (combination of high-dose rosuvastatin and ezetimibe). Administration group) and control group (high-dose rosuvastatin single administration group) are randomly assigned in a 1:1 ratio.\n\nClinical investigational drugs according to randomization are administered to hospitalized patients, and when discharged, they are allowed to take the provided clinical investigational drugs for a total of 90 days. After the baseline, on the 7th day or at discharge (1st follow-up), and on the 30th day (2nd follow-up), compliance with medication and occurrence of adverse reactions are observed, and on the 90th day (3rd follow-up), lipid concentration test is performed. Check LDL-C levels and compare with baseline LDL-C levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Those with primary hypercholesterolemia among those whose lesions were confirmed by brain CT or MRI within 48 hours of the onset of ischemic stroke\n2. Adults 19 years of age or older\n3. Patients who agreed to participate in this study\n\nExclusion Criteria:\n\n1. Patients scheduled for carotid endarterectomy or stenting, cerebral artery stenting, coronary angioplasty and stenting, or coronary artery bypass surgery within 3 months\n2. Patients with malignant tumors that have not been cured\n3. Patients who have participated in other drug clinical trials within the last 30 days\n4. Patients expected to experience side effects when taking rosuvastatin and ezetimibe\n5. Patients who did not consent to participate in this study'}, 'identificationModule': {'nctId': 'NCT05884502', 'briefTitle': 'A Multicenter Study to Evaluate the Effect of High Dose Rosuvastatin Versus Rosuvastatin and Ezetimibe in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'A Multicenter Prospective Randomized-controlled Interventional Study to Evaluate the Effect of High Dose Rosuvastatin Versus High Dose Rosuvastatin and Ezetimibe in Acute Ischemic Stroke Patients', 'orgStudyIdInfo': {'id': '2021AN0073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination therapy', 'description': 'combination of high-dose rosuvastatin and ezetimibe', 'interventionNames': ['Drug: combination of high-dose rosuvastatin and ezetimibe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single therapy', 'description': 'high-dose rosuvastatin single administration group', 'interventionNames': ['Drug: high-dose rosuvastatin single administration']}], 'interventions': [{'name': 'combination of high-dose rosuvastatin and ezetimibe', 'type': 'DRUG', 'description': 'combination of rosuvastatin 20mg and ezetimibe 10mg', 'armGroupLabels': ['Combination therapy']}, {'name': 'high-dose rosuvastatin single administration', 'type': 'DRUG', 'description': 'rosuvastatin 20mg monotherapy', 'armGroupLabels': ['Single therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15355', 'city': 'Ansan', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Man Jung, M.D.', 'role': 'CONTACT', 'email': 'sodium75@hanmail.net'}], 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.21795, 'lon': 127.55845}}, {'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sungwook Yu, M.D.', 'role': 'CONTACT', 'email': 'song4yu@korea.ac.kr', 'phone': '82-2-920-5510'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chi-Kyung Kim, M.D.', 'role': 'CONTACT', 'email': 'ckkim7@gmail.com'}], 'facility': 'Koera University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sungwook Yu, M.D.', 'role': 'CONTACT', 'email': 'song4yu@korea.ac.kr', 'phone': '82-2-920-5510'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yu, Sungwook', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}