Intracranial Arterial DiseasesNCT02341794
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
A study testing Rosuvastatin in people with Intracranial Arterial Diseases, run by Tokyo Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Intracranial Arterial Diseases
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2015to Jul 2018
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 30 and 80 years of age.
- Patients with noncardioembolic ischemic stroke
- Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.
- LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
- Patients taking clopidogrel as antiplatelet therapy when providing informed consent
- Patients considered to be able to visit the study site
- Patients who provided written informed consent
Who cannot join
- Any haemorrhagic stroke or haemorrhagic infarction
- Familial hypercholesterolemia
- Patients with uncontrolled angina pectoris or congestive heart failure
- Patients with severe liver or renal dysfunction
- Patients with a malignant tumor requiring treatment
- Patients with uncontrolled diabetes mellitus
Show all 9Show fewer
- Patients with secondary dyslipidemia (due to corticosteroid etc)
- Patients with a history of myopathy
- Patients considered by the investigator to be unsuitable for participating in this study
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tokyo Medical University
Shinjuku-ku, Tokyo, 160-8402
Daisuke Nishi, M.D., Ph.D.
About this study
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
Read the detailed description
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.
- Conditions
- Intracranial Arterial Diseases
- Being tested
- Rosuvastatin
- Keywords
- intracranial arterial disease, dyslipidemia, rosuvastatin
- Medical subject headings
- Intracranial Arterial Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Rosuvastatin (5mg) will be orally administrated once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of intracranial arterial stenosis after two years
Measured: 6 months, 1 year and 2 years
Secondary outcomes (13)
Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)
Measured: 6 months, 1 year and 2 years
Ischemic stroke or transient ischemic attack
Measured: 6 months, 1 year and 2 years
Intracerebral haemorrhage or subarachnoid haemorrhage
Measured: 6 months, 1 year and 2 years
Death from any cause
Measured: 6 months, 1 year and 2 years
Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events
Measured: 6 months, 1 year and 2 years
The change of percentage in LDL-C from baseline
Measured: 6 months, 1 year and 2 years
The change in HDL-C level from baseline
Measured: 6 months, 1 year and 2 years
Intracranial haemorrhage
Measured: 6 months, 1 year and 2 years
Number of cerebral microbleeds on MRI
Measured: 6 months, 1 year and 2 years
Carotid intima-media thickness
Measured: 6 months, 1 year and 2 years
Ankle brachial index
Measured: 6 months, 1 year and 2 years
Brachial-ankle pulse wave velocity
Measured: 6 months, 1 year and 2 years
Adverse events and adverse drug reactions
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arterial DiseasesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hitoshi Aizawa, MD, PhD, Principal investigator, Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341794
- Sponsor's protocol ID
- 2900
- Status last verified
- Jan 2015
- First submitted
- 14 Jan 2015
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
- ClinicalTrials.gov ID
- NCT02341794
- Acronym / sponsor ID
- 2900
- Conditions
- Intracranial Arterial Diseases
- Keywords
- intracranial arterial disease, dyslipidemia, rosuvastatin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Jan 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.
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
Detailed description
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients between 30 and 80 years of age.
- Patients with noncardioembolic ischemic stroke
- Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.
- LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
- Patients taking clopidogrel as antiplatelet therapy when providing informed consent
Key exclusion criteria (9 listed)
- Any haemorrhagic stroke or haemorrhagic infarction
- Familial hypercholesterolemia
- Patients with uncontrolled angina pectoris or congestive heart failure
- Patients with severe liver or renal dysfunction
- Patients with a malignant tumor requiring treatment
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 |
|---|---|---|
| RosuvastatinRosuvastatin (5mg) will be orally administrated once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8 mmol/L. | Drug | Rosuvastatin |
Primary outcome
Progression of intracranial arterial stenosis after two years
Time frame: 6 months, 1 year and 2 years
13 secondary outcomes
Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)
Time frame: 6 months, 1 year and 2 years
Ischemic stroke or transient ischemic attack
Time frame: 6 months, 1 year and 2 years
Intracerebral haemorrhage or subarachnoid haemorrhage
Time frame: 6 months, 1 year and 2 years
Death from any cause
Time frame: 6 months, 1 year and 2 years
Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events
Time frame: 6 months, 1 year and 2 years
The change of percentage in LDL-C from baseline
Time frame: 6 months, 1 year and 2 years
The change in HDL-C level from baseline
Time frame: 6 months, 1 year and 2 years
Intracranial haemorrhage
Time frame: 6 months, 1 year and 2 years
Number of cerebral microbleeds on MRI
Time frame: 6 months, 1 year and 2 years
Carotid intima-media thickness
Time frame: 6 months, 1 year and 2 years
Ankle brachial index
Time frame: 6 months, 1 year and 2 years
Brachial-ankle pulse wave velocity
Time frame: 6 months, 1 year and 2 years
Adverse events and adverse drug reactions
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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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.
Hitoshi Aizawa, MD, PhD principal investigator
Tokyo Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin in people with Intracranial Arterial Diseases, run by Tokyo Medical University at 1 site in Japan.
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 7 inclusion and 9 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 21 Jan 2015. 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 Japan. 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.
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 Hitoshi Aizawa, MD, PhD (+813-3342-6111 ext. 2155, haizawa@tokyo-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of intracranial arterial stenosis after two years (time frame: 6 months, 1 year and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2015.