Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

Phase 4

• Conditions: Stroke; Intracranial Atherosclerosis

• Registration Number: NCT02458755
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-01
• Status Verified: 2016-10
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in vascular remodeling before and after the statin treatment	During initial admission and 6 months from stroke onset	Changes in vascular remodeling before and after the statin treatment: Difference of lumen area, vessel area, wall area, remodeling index, wall area index, plaque volume, plaque composition and enhancement pattern on high-resolution MRI

Secondary Outcome Measures

Name	Time	Method
Recurrent stroke/Transient ischemic attack	Admission to study completion date, an expected average of 1 year
Elevated liver function test or muscle enzyme levels	During initial admission, an expected average of 1 week, and 1 and 3 month after discharge	Abnormal laboratory findings of elevated liver function test or muscle enzyme levels
All causes of death	Admission to study completion date, an expected average of 1 year	All causes of death including vascular and non-vascular death
Exploration of biomarkers	During initial admission, an expected average of 1 week	Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response.

Trial Locations

Locations (1)

Oh Young Bang; 🇰🇷 Seoul, Korea, Republic of