StrokePhase 4STAMINA-MRINCT02458755
Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis
A Phase 4 study testing High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg in people with Stroke and Intracranial Atherosclerosis, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Intracranial Atherosclerosis
- What is being tested?
- High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Oh Young Bang
Seoul, 135-710
Oh Young Bang, MD, PhD, +82-2-3410-3599, ohyoungbang@samsung.com
Jong-Won Chung, MD, Msc, +82-10-9032-9906, neurocjw@gmail.com
About this study
Official title: 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.
- Conditions
- Stroke, Intracranial Atherosclerosis
- Being tested
- High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg
- Medical subject headings
- Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mgDrug
Also called Atorvastatin 40mg or Rosuvastatin 20mg
Atorvastatin 40mg or Rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| High-dose statin treatment | Experimental | Atorvastatin (40mg) or Rosuvastatin (20mg) Receives: Drug: High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During initial admission and 6 months from stroke onset
Secondary outcomes (4)
Elevated liver function test or muscle enzyme levels
Abnormal laboratory findings of elevated liver function test or muscle enzyme levels
Measured: During initial admission, an expected average of 1 week, and 1 and 3 month after discharge
Recurrent stroke/Transient ischemic attack
Measured: Admission to study completion date, an expected average of 1 year
All causes of death
All causes of death including vascular and non-vascular death
Measured: Admission to study completion date, an expected average of 1 year
Exploration of biomarkers
Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response.
Measured: During initial admission, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startFeb 2012
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Don-A Pharmaceutical, Seoul, South Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458755
- Sponsor's protocol ID
- SMC 2011-12-053
- Acronym
- STAMINA-MRI
- Status last verified
- Oct 2016
- First submitted
- 5 May 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37056360Chung 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.
PubMed 31371644
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study)
- ClinicalTrials.gov ID
- NCT02458755
- Acronym / sponsor ID
- STAMINA-MRI / SMC 2011-12-053
- Conditions
- Stroke, Intracranial Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Don-A Pharmaceutical, Seoul, South Korea
- Study start
- Feb 2012
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-dose statin treatment | Experimental | Drug: High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mgAtorvastatin (40mg) or Rosuvastatin (20mg) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mgAlso: Atorvastatin 40mg or Rosuvastatin 20mgAtorvastatin 40mg or Rosuvastatin 20mg | Drug | High-dose statin treatment |
Primary outcome
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
4 secondary outcomes
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
Recurrent stroke/Transient ischemic attack
Time frame: 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
Exploration of biomarkers
Time frame: During initial admission, an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 37056360Sim 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.
- Derived from this study: PubMed 31371644Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg in people with Stroke and Intracranial Atherosclerosis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oh Young Bang, MD, PhD (+82-2-3410-3599, ohyoungbang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in vascular remodeling before and after the statin treatment (time frame: During initial admission and 6 months from stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458755, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.