Intracranial Arterial StenosisPhase 4REALMNCT02041117
Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging
A Phase 4 study testing Rosuvastatin in people with Intracranial Arterial Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
1. It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing LDL-C level to or less than 70mg/dl. 2. Ischemic stroke patients will be enrolled within 1 month after stroke onset. 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Arterial Stenosis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2014to 6 Nov 2018
- Phase
- Phase 4
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 75 years of age.
- Ischemic stroke originate from middle cerebral artery(MCA) AS stenosis, stroke onset within 1 month.
- LDL-C level is more than 70mg/dl (1.8mmol/L), but less than 250mg/dl (6.5mmol/L); and triglyceride level is less than 353mg/dl (4.0mmol/L).
- total term of statin therapy less than 2 month in past 1year before entering the study.
- （5）30-70% intracranial artery stenosis in M1 segment of MCA comfirmed by CTA or MRI at least 1 or more atherosclerotic plaques in M1 segment of MCA is detectable.
- （6）Female patients must agree to use an effective form of birth control throughout the 2-year study treatment period.
Show all 9Show fewer
- （7）The patients who are willing to be enrolled have to remain on the low cholesterol dietary for the study duration.
- （8）The patient must be able to comply with scheduled visits, the treatment plan and all laboratory tests.
- （9）Written informed consent is provided to participate in the study.
Who cannot join
- Any hemorrhagic stroke or hemorrhagic infarction
- Presence of any of cardiac sources of embolism
- Ischemic stroke caused by non MCA stenosis
- The patients has LDL cholesterol ≤ 70mg/dl or familial hypercholesterolemia.
- Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty within 2 years
- Any aneurysm proximal to or distal to stenotic intracranial artery
Show all 27Show fewer
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours before enrollmentnt
- The patient has plans for surgical/endovascular intervention for intracranial, carotid, coronary and/or peripheral arterial disease during the course of the study.
- The patient has or is being treated or evaluated for diagnosed tuberculosis.
- The patient has a history of malignant neoplasm within the previous 5 years (exception: curable non-melanoma skin malignancies).
- The patient has a known immunodeficient state (e.g., human immunodeficiency virus) or is being treated with immunosuppressive drugs including cyclosporine.
- The patient has any other clinically significant medical condition that, in the opinion of the Investigator, could impact the patient's ability to successfully complete the trial.
- Life expectancy of patients is less than 2 years.
- The patient have to take medicines as follow: Hormonal therapy, Cyclosporine and other lipid lowering agents: fish oil, garlic essential oil etc.
- The patient has a history of recent alcohol abuse, drug abuse or significant mental illness.
- The patient has any condition that would prevent the patient from giving voluntary informed consent.
- The patient has an inability to tolerate oral medication administration.
- The patient has a known or suspected allergy to the study medication(s) or the class of study medication to be administered.
- The patients cannot finish HR-MRI for any reasons.
- Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
- The patient is enrolled or plans to enroll in another clinical drug or device/interventional trial during this study.
- The patient has the history of epilepsy/seizures.
- The patient has liver function tests > 1.5 times the upper limit of normal, serum creatinine > 2.0 mg/dL, GFR < 30 ml/min or has abnormal laboratory values which are deemed clinically significant by the investigator.
- The patient has the history of myopathy.
- The patient has thyroid stimulating hormone > 1.5xULN.
- BMI ≥ 30 kg/m2
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital affliated to Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging in Two Years
- It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing LDL-C level to or less than 70mg/dl.
- Ischemic stroke patients will be enrolled within 1 month after stroke onset.
- Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.
- Conditions
- Intracranial Arterial Stenosis
- Being tested
- Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin, 10mg for 4-weeks, then according to the results of the LDL-C, adjust dose of rosuvastatin, maximum to 20 mg/d, to reduce LDL-C under 70 mg/dl for two years.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Other | Not described Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the percentage of volume of MCA atherosclerosis plaque after 2 years treatment of Rosuvastatin 10-20mg
Measured: 2 year
Secondary outcomes (17)
The change in Percentage of plaque volume of M1segment plaque
Measured: 6 months and 1 year
The change in Percentage of lumen volume
Measured: 2 years
The change in percentage of lipid rich necrotic core
Measured: 2 years
Recurrency of stroke or TIA
Measured: 2 years
The change of percentage in LDL-C from baseline
Measured: 2 years
The change in HDL-C level from baseline
Measured: 2 years
To explore the relationship between the change of plaque volumn and morphology and the change in LDL-C, HDL-C and Hs-CRP level
Measured: 2 years
safety-Rhabdomyolysis，Hepatonecrosis
Measured: 2 years
The change in percentage of thickness of fibrous cap
Measured: 2 years
The change in percentage of intraplaque hemorrhage
Measured: 2 years
The change in hsCRP level from baseline
Measured: 2 years
2.Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage
Measured: 2 years
Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months
Measured: 2 years
Moderate bleeding (GUSTO definition)
Measured: 2 years
Intracranial hemorrhage
Measured: 2 years
Total mortality
Measured: 2 years
AEs/SAEs reported by the investigators
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start24 Feb 2014
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arterial StenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041117
- Sponsor's protocol ID
- 2012ZX09303-005-001
- Acronym
- REALM
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2014
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No