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

April 25, 2017 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Atorvastatin 40mg or Rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During initial admission and 6 months from stroke onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During initial admission, an expected average of 1 week, and 1 and 3 month after discharge
Recurrent stroke/Transient ischemic attack
Time Frame: Admission to study completion date, an expected average of 1 year
Admission to study completion date, an expected average of 1 year
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
Admission to study completion date, an expected average of 1 year
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.
During initial admission, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Don-A Pharmaceutical, Seoul, South Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2011-12-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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