Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJanuary 21, 2015
January 1, 2015
2.9 years
January 14, 2015
January 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of intracranial arterial stenosis after two years
6 months, 1 year and 2 years
Secondary Outcomes (13)
Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)
6 months, 1 year and 2 years
Ischemic stroke or transient ischemic attack
6 months, 1 year and 2 years
Intracerebral haemorrhage or subarachnoid haemorrhage
6 months, 1 year and 2 years
Death from any cause
6 months, 1 year and 2 years
Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events
6 months, 1 year and 2 years
- +8 more secondary outcomes
Study Arms (1)
Rosuvastatin
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Male or female patients between 30 and 80 years of age.
- Patients with noncardioembolic ischemic stroke
- 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.
- LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
- Patients taking clopidogrel as antiplatelet therapy when providing informed consent
- Patients considered to be able to visit the study site
- Patients who provided written informed consent
You may not qualify if:
- Any haemorrhagic stroke or haemorrhagic infarction
- Familial hypercholesterolemia
- Patients with uncontrolled angina pectoris or congestive heart failure
- Patients with severe liver or renal dysfunction
- Patients with a malignant tumor requiring treatment
- Patients with uncontrolled diabetes mellitus
- Patients with secondary dyslipidemia (due to corticosteroid etc)
- Patients with a history of myopathy
- Patients considered by the investigator to be unsuitable for participating in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Medical University
Shinjuku-ku, Tokyo, 160-8402, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hitoshi Aizawa, MD, PhD
Tokyo Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 19, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
January 21, 2015
Record last verified: 2015-01