Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

Stroke Clinical Trial

— STAMINA-MRI  

Official title:

Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02458755
• Other study ID #: SMC 2011-12-053
• Status: Recruiting
• Phase: Phase 4
• First received: May 5, 2015
• Last updated: April 25, 2017
• Start date: February 2012
• Est. completion date: June 2018

Study information

• Verified date: October 2016
• Source: Samsung Medical Center
• Contact: Oh Young Bang, MD, PhD
• Phone: +82-2-3410-3599
• Email: ohyoungbang[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Stroke

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Oh Young Bang	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Don-A Pharmaceutical, Seoul, South Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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