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

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ClinicalTrials.gov Identifier: NCT02458755
Recruitment Status : Unknown
Verified October 2016 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : June 1, 2015
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Don-A Pharmaceutical, Seoul, South Korea
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Intracranial Atherosclerosis Drug: High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study)
Study Start Date : February 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: High-dose statin treatment
Atorvastatin (40mg) or Rosuvastatin (20mg)
Drug: High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg
Atorvastatin 40mg or Rosuvastatin 20mg
Other Name: Atorvastatin 40mg or Rosuvastatin 20mg




Primary Outcome Measures :
  1. Changes in vascular remodeling before and after the statin treatment [ Time Frame: 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 :
  1. 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 ]
    Abnormal laboratory findings of elevated liver function test or muscle enzyme levels

  2. Recurrent stroke/Transient ischemic attack [ Time Frame: Admission to study completion date, an expected average of 1 year ]
  3. All causes of death [ Time Frame: Admission to study completion date, an expected average of 1 year ]
    All causes of death including vascular and non-vascular death

  4. Exploration of biomarkers [ Time Frame: During initial admission, an expected average of 1 week ]
    Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458755


Contacts
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Contact: Oh Young Bang, MD, PhD +82-2-3410-3599 ohyoungbang@samsung.com
Contact: Jong-Won Chung, MD, Msc +82-10-9032-9906 neurocjw@gmail.com

Locations
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Korea, Republic of
Oh Young Bang Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Oh Young Bang, MD, PhD    +82-2-3410-3599    ohyoungbang@samsung.com   
Contact: Jong-Won Chung, MD, Msc    +82-10-9032-9906    neurocjw@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Don-A Pharmaceutical, Seoul, South Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02458755     History of Changes
Other Study ID Numbers: SMC 2011-12-053
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: October 2016
Additional relevant MeSH terms:
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Stroke
Intracranial Arteriosclerosis
Atherosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Intracranial Arterial Diseases
Atorvastatin
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors