Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging

NCT02041117 | Completed Phase 4

• 1 other identifier: 2012ZX09303-005-001
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Ischemic stroke patients will be enrolled within 1 month after stroke onset.
3. 3.Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.

Conditions

Intracranial Arterial Stenosis

Outcome Measures

Primary Outcomes (1)

• The change in the percentage of volume of MCA atherosclerosis plaque after 2 years treatment of Rosuvastatin 10-20mg

  2 year

Secondary Outcomes (17)

• The change in Percentage of plaque volume of M1segment plaque

  6 months and 1 year

• The change in Percentage of lumen volume

  2 years

• The change in percentage of lipid rich necrotic core

  2 years

• Recurrency of stroke or TIA

  2 years

• The change of percentage in LDL-C from baseline

  2 years

Study Arms (1)

Rosuvastatin

OTHER

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

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.

Also known as: Crestor

Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• （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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital affliated to Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 20, 2014
• Study Start: February 24, 2014
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

CN (1)