Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Intracranial Atherosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-dose statin treatment

Atorvastatin (40mg) or Rosuvastatin (20mg)

Group Type EXPERIMENTAL

High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg

Intervention Type DRUG

Atorvastatin 40mg or Rosuvastatin 20mg

Interventions

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High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg

Atorvastatin 40mg or Rosuvastatin 20mg

Intervention Type DRUG

Other Intervention Names

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Atorvastatin 40mg or Rosuvastatin 20mg

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No