Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT02341794
Status:
UNKNOWN
Last Update Posted:
2015-01-21
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-17', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of intracranial arterial stenosis after two years', 'timeFrame': '6 months, 1 year and 2 years'}], 'secondaryOutcomes': [{'measure': 'Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Ischemic stroke or transient ischemic attack', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Intracerebral haemorrhage or subarachnoid haemorrhage', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Death from any cause', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'The change of percentage in LDL-C from baseline', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'The change in HDL-C level from baseline', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Intracranial haemorrhage', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Number of cerebral microbleeds on MRI', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Carotid intima-media thickness', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Ankle brachial index', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Brachial-ankle pulse wave velocity', 'timeFrame': '6 months, 1 year and 2 years'}, {'measure': 'Adverse events and adverse drug reactions', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intracranial arterial disease', 'dyslipidemia', 'rosuvastatin'], 'conditions': ['Intracranial Arterial Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.', 'detailedDescription': 'The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients between 30 and 80 years of age.\n2. Patients with noncardioembolic ischemic stroke\n3. Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.\n4. LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia\n5. Patients taking clopidogrel as antiplatelet therapy when providing informed consent\n6. Patients considered to be able to visit the study site\n7. Patients who provided written informed consent\n\nExclusion Criteria:\n\n1. Any haemorrhagic stroke or haemorrhagic infarction\n2. Familial hypercholesterolemia\n3. Patients with uncontrolled angina pectoris or congestive heart failure\n4. Patients with severe liver or renal dysfunction\n5. Patients with a malignant tumor requiring treatment\n6. Patients with uncontrolled diabetes mellitus\n7. Patients with secondary dyslipidemia (due to corticosteroid etc)\n8. Patients with a history of myopathy\n9. Patients considered by the investigator to be unsuitable for participating in this study'}, 'identificationModule': {'nctId': 'NCT02341794', 'briefTitle': 'Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Tokyo Medical University'}, 'officialTitle': 'Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography', 'orgStudyIdInfo': {'id': '2900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Rosuvastatin (5mg) will be orally administrated once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8 mmol/L.', 'armGroupLabels': ['Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160-8402', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Daisuke Nishi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tokyo Medical University'}], 'centralContacts': [{'name': 'Hitoshi Aizawa, MD, PhD', 'role': 'CONTACT', 'email': 'haizawa@tokyo-med.ac.jp', 'phone': '+813-3342-6111', 'phoneExt': '2155'}], 'overallOfficials': [{'name': 'Hitoshi Aizawa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokyo Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}