Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

NCT02458755 | Unknown Phase 4

• 1 other identifier: SMC 2011-12-053
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

  During initial admission and 6 months from stroke onset

Secondary Outcomes (4)

• Elevated liver function test or muscle enzyme levels

  During initial admission, an expected average of 1 week, and 1 and 3 month after discharge

• Recurrent stroke/Transient ischemic attack

  Admission to study completion date, an expected average of 1 year

• All causes of death

  Admission to study completion date, an expected average of 1 year

• Exploration of biomarkers

  During initial admission, an expected average of 1 week

Study Arms (1)

High-dose statin treatment

EXPERIMENTAL

Atorvastatin (40mg) or Rosuvastatin (20mg)

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

Interventions

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

Atorvastatin 40mg or Rosuvastatin 20mg

Also known as: Atorvastatin 40mg or Rosuvastatin 20mg

High-dose statin treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Don-A Pharmaceutical, Seoul, South Korea: collaborator

Study Sites (1)

Oh Young Bang

Seoul, 135-710, South Korea

RECRUITING

Related Publications (2)

• Sim JE, Song HN, Choi JU, Lee JE, Baek IY, Cho HH, Kim JH, Chung JW, Kim GM, Park HJ, Bang OY, Seo WK. The effect of intensive statin therapy in non-symptomatic intracranial arteries: The STAMINA-MRI sub-study. Front Neurol. 2023 Mar 28;14:1069502. doi: 10.3389/fneur.2023.1069502. eCollection 2023.

  PMID: 37056360 DERIVED

• 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.

  PMID: 31371644 DERIVED

MeSH Terms

Conditions

Stroke; Intracranial Arteriosclerosis

Interventions

Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Oh Young Bang, MD, PhD

CONTACT

+82-2-3410-3599; ohyoungbang@samsung.com

Jong-Won Chung, MD, Msc

CONTACT

+82-10-9032-9906; neurocjw@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: June 1, 2015
• Study Start: February 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2016-10

Locations

KR (1)