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Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis (STAMINA-MRI)

Primary Purpose

Stroke, Intracranial Atherosclerosis

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oh Young BangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-dose statin treatment

Arm Description

Atorvastatin (40mg) or Rosuvastatin (20mg)

Outcomes

Primary Outcome Measures

Changes in vascular remodeling before and after the statin treatment
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

Elevated liver function test or muscle enzyme levels
Abnormal laboratory findings of elevated liver function test or muscle enzyme levels
Recurrent stroke/Transient ischemic attack
All causes of death
All causes of death including vascular and non-vascular death
Exploration of biomarkers
Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response.

Full Information

First Posted
May 5, 2015
Last Updated
April 25, 2017
Sponsor
Samsung Medical Center
Collaborators
Don-A Pharmaceutical, Seoul, South Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02458755
Brief Title
Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis
Acronym
STAMINA-MRI
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Don-A Pharmaceutical, Seoul, South Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Intracranial Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose statin treatment
Arm Type
Experimental
Arm Description
Atorvastatin (40mg) or Rosuvastatin (20mg)
Intervention Type
Drug
Intervention Name(s)
High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg
Other Intervention Name(s)
Atorvastatin 40mg or Rosuvastatin 20mg
Intervention Description
Atorvastatin 40mg or Rosuvastatin 20mg
Primary Outcome Measure Information:
Title
Changes in vascular remodeling before and after the statin treatment
Description
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
Time Frame
During initial admission and 6 months from stroke onset
Secondary Outcome Measure Information:
Title
Elevated liver function test or muscle enzyme levels
Description
Abnormal laboratory findings of elevated liver function test or muscle enzyme levels
Time Frame
During initial admission, an expected average of 1 week, and 1 and 3 month after discharge
Title
Recurrent stroke/Transient ischemic attack
Time Frame
Admission to study completion date, an expected average of 1 year
Title
All causes of death
Description
All causes of death including vascular and non-vascular death
Time Frame
Admission to study completion date, an expected average of 1 year
Title
Exploration of biomarkers
Description
Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response.
Time Frame
During initial admission, an expected average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh Young Bang, MD, PhD
Phone
+82-2-3410-3599
Email
ohyoungbang@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Won Chung, MD, Msc
Phone
+82-10-9032-9906
Email
neurocjw@gmail.com
Facility Information:
Facility Name
Oh Young Bang
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD, PhD
Phone
+82-2-3410-3599
Email
ohyoungbang@samsung.com
First Name & Middle Initial & Last Name & Degree
Jong-Won Chung, MD, Msc
Phone
+82-10-9032-9906
Email
neurocjw@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31371644
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.
Results Reference
derived

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Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

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