Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 6:40 PM
Study NCT ID:
NCT04433533
Status:
UNKNOWN
Last Update Posted:
2021-01-15
First Post:
2020-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum level of low-density lipoprotein cholesterol', 'timeFrame': '24 weeks', 'description': 'Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy'}, {'measure': 'Change in serum level of low-density lipoprotein cholesterol', 'timeFrame': '48 weeks', 'description': 'Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy'}], 'secondaryOutcomes': [{'measure': 'Improvement of diastolic dysfunction', 'timeFrame': '48 weeks'}, {'measure': 'Improvement of ventriculoarterial coupling index', 'timeFrame': '48 weeks'}, {'measure': 'Improvement of peak VO2', 'timeFrame': '48 weeks'}, {'measure': 'Improvement of 6 minute walking test combination therapy and monotherapy', 'timeFrame': '48 weeks'}, {'measure': 'Clinical outcomes including death rate', 'timeFrame': '48 weeks'}, {'measure': 'Clinical outcomes including readmission rate', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Ventricular Diastolic Dysfunction', 'Hyperlipidemias']}, 'descriptionModule': {'briefSummary': 'preserved left ventricular ejection fraction (LVEF ≥ 50%) and are accompanied by dyslipidemia (LDL ≥ 100 mg / dl) will be enrolled.\n\nOnly patients who do not meet the exclusion criteria should be enrolled in the study.\n\nOnce the patient is selected, the patient is informed of the study and receives the consent form.\n\nPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly assigned in a 1: 1 dose of rosuvastatin/ezetimibe 10/10mg once daily or rosuvastatin 20 mg once daily. Patients who previously used statins have a wash-out period of 4 weeks or more.\n\nPatients will visit outpatient clinic at 12 weeks and 24 weeks after initiation of treatment. Physical examination, blood test, and 6 minute working test will be performed. For fasting blood tests, patients visit on an empty stomach. Drug adverse events and changes in vital signs or body weight will be checked.\n\nAfter 48 weeks of treatment, the patients will visit outpatient clinic for efficacy evaluation; physical examination, blood test, transthoracic echocardiography, cardiopulmonary exercise test, central blood pressure, and pulse wave velocity. Drug adverse events and medication compliance will be checked.\n\nThe primary endpoint is change of low-density lipoprotein cholesterol and secondary endpoint is improvement of diastolic dysfunction, VAC index, peak VO2, distance of 6 minute working test, and clinical outcomes including death, readmission rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who have left ventricular diastolic dysfunction (relaxation abnormality, pseudonormalization, restrictive pattern) with preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)\n2. Adult participants (≥ 20 years old) who have dyslipidemia and need treatment\n3. Patients who understand the information about the trial and voluntarily agree to participate in the trial\n\nExclusion Criteria:\n\n1. Baseline fasting low-density lipoprotein cholesterol ≤ 70 mg/dL\n2. Baseline fasting triglyceride ≥ 400 mg/dL\n3. Baseline fasting total cholesterol ≥ 300 mg/dL\n4. Participants who have structural heart disease\n5. Participants who have prior acute coronary syndrome or cerebrovascular attack within 3 months.\n6. Renal dysfunction (estimated glomerular filtration rate \\< 30mL/min/1.73m2)\n7. Creatinine phosphokinase elevations greater than three times the upper limit of normal\n8. Aspartate or alanine aminotransferase elevations greater than three times the upper limit of normal\n9. Previous history of rhabdomyolysis\n10. Females who are pregnant or breastfeeding or have a plan for pregnancy\n11. Life expectancy less than a year.'}, 'identificationModule': {'nctId': 'NCT04433533', 'briefTitle': 'Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Randomized, Single-center, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia', 'orgStudyIdInfo': {'id': '4-2019-1125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin 20mg (Group 1)', 'interventionNames': ['Drug: Rosuvastatin 20']}, {'type': 'EXPERIMENTAL', 'label': 'Rosuvamibe 10/10mg (Group 2)', 'interventionNames': ['Drug: Rosuvamibe 10/10']}], 'interventions': [{'name': 'Rosuvastatin 20', 'type': 'DRUG', 'description': 'Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of Rosuvastatin 20mg Monotherapy.', 'armGroupLabels': ['Rosuvastatin 20mg (Group 1)']}, {'name': 'Rosuvamibe 10/10', 'type': 'DRUG', 'description': 'Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin10mg/ezetimibe 10mg combination Therapy', 'armGroupLabels': ['Rosuvamibe 10/10mg (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Geu-Ru Hong', 'role': 'CONTACT', 'email': 'grhong@yuhs.ac', 'phone': '82-2-2228-8443'}], 'facility': 'Yonsei Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Geu-Ru Hong', 'role': 'CONTACT', 'email': 'grhong@yuhs.ac', 'phone': '82-2-2228-8443'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}