Clinical trial NCT02458755: Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis
Official title: Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Intracranial Atherosclerosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Don-A Pharmaceutical, Seoul, South Korea
First posted: 2015-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: Intracranial atherosclerosis is a common condition in Korean population consisting over 25% of ischemic stroke etiology. American Stroke Association and Korean Stroke Society recommend antiplatelet and statin for the treatment of intracranial atherosclerosis. Besides lowering blood cholesterol levels statin also stabilize atherosclerotic plaque and eventually lower the risk of ischemic stroke. However, little evidence resides on the effect of statin treatment on intracranial atherosclerosis. Recent advance in high-tesla magnetic resonance imaging enables direct imaging of intracranial atherosclerotic plaque and further assessment of treatment efficacy of statin in stabilization of intracranial atherosclerotic plaque became possible.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke patients within 7 days of symptom onset
* Symptomatic intracranial artery stenosis (above 30%) at proximal portion of middle cerebral artery (MCA), basilar artery, or intracranial portion of intracranial artery (ICA).
* Not receiving statins (HMA-coA reductase)
* Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Extracranial artery (carotid artery bifurcation, proximal vertebral artery) stenosis above 50%
* Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
* Severe hepatic or renal dysfunction
* Pregnant females as determined by positive urine hCG test or lactating females
* Subjects considered unwilling or unable to comply with the imaging procedures and study visit schedule

Primary outcomes:
measure: Changes in vascular remodeling before and after the statin treatment
timeFrame: During initial admission and 6 months from stroke onset
Secondary outcomes:
measure: Elevated liver function test or muscle enzyme levels
timeFrame: During initial admission, an expected average of 1 week, and 1 and 3 month after discharge
measure: Recurrent stroke/Transient ischemic attack
timeFrame: Admission to study completion date, an expected average of 1 year
measure: All causes of death
timeFrame: Admission to study completion date, an expected average of 1 year
measure: Exploration of biomarkers
timeFrame: During initial admission, an expected average of 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Oh Young Bang
Study officials:
References:
citation: Chung JW, Cha J, Lee MJ, Yu IW, Park MS, Seo WK, Kim ST, Bang OY. Intensive Statin Treatment in Acute Ischaemic Stroke Patients with Intracranial Atherosclerosis: a High-Resolution Magnetic Resonance Imaging study (STAMINA-MRI Study). J Neurol Neurosurg Psychiatry. 2020 Feb;91(2):204-211. doi: 10.1136/jnnp-2019-320893. Epub 2019 Aug 1.