Intensive Rosuvastatin Therapy on Cerebral Hemodynamics in Patients With Atherosclerotic Intracranial Arterial Stenosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of
      the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis
      accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and other
      countries in Asia. AICAS is also highly associated with the risk of stroke recurrence.
      Possible mechanisms of cerebral infarction secondary to AICAS are likely linked with
      hemodynamic compromise distal to site of stenosis.

      Computed tomography perfusion (CTP) can be used to evaluate vasoreactivity and
      cerebrovascular reserve in patients with AICAS and predict future stroke. The parameters of
      CTP include ①cerebral blood flow(CBF),② cerebral blood volume(CBV) and ③mean transit
      time(MTT). Relative regional cerebral blood flow (rCBF) was evaluated as the percentage
      radioisotope counts in the region of interest (ROI) of the affected side against the
      corresponding ROI in the unaffected contralateral side.

      Statins can decrease the incidence of transient ischemic attack or ischemic stroke and
      improve stroke outcome. Few studies focus on the relationship between statins therapy and
      cerebral perfusion.

      Whether intensive rosuvastatin therapy compared with standard rosuvastatin therapy can
      improve hemodynamic situation and cerebral perfusion status in AICAS has not been
      illustrated.

      Based on those studies, the investigators hypothesized that intensive rosuvastatin may also
      improve the symptoms of AICAS not only through enhancing the stability of atherosclerotic
      plaques, but also its pleiotropic effects. So it can change the hemodynamic status around the
      plaque and increase cerebral flow in the downstream territory. So in this study the
      investigators try to analysis statin's impact on the hemodynamic changes as well as the
      downstream perfusion which is determined by CTP.
    

Detailed description: 
      This is an prospective, randomized, single-blind, single center clinical trial to evaluate
      the effect of intensive rosuvastatin therapy compared with standard rosuvastatin therapy on
      improve the cerebral perfusion in Chinese patients with atherosclerotic intracranial arterial
      stenosis between 50-99%.

      The study will enroll 44 patients and randomly divided into 2 groups: standard dose
      rosuvastatin therapy (SRT 10mg/day)and intensive dose rosuvastatin therapy (IRT 20mg/day)in a
      1:1 ratio. Both groups will be prescribed with statin based on other routine medication for
      stroke for 52 weeks. CTP will be performed at baseline and 52 weeks after treatment. Lipid
      levels and biochemical examinations will be obtained at baseline and 13, 26, 39, 52 week.
      AEs(Adverse Events)/SAEs(Serious Adverse Events) will be collected and recorded in CRF(Case
      Report Form) from the signing of informed consent throughout the study until and including
      the last visit.

      Study Endpoints: Primary endpoint: Compared with standard dose rosuvastatin therapy 10mg/day,
      the change of relative cerebral blood flow (CBF) by CTP after intensive dose rosuvastatin
      therapy 20mg/day treatment for 52 weeks.Secondary endpoints: (1) Compared with standard dose
      rosuvastatin therapy 10mg/day, the changes of relative cerebral blood volume (CBV) by CTP
      after rosuvastatin 20mg/d treatment for 52 weeks (2) Compared with standard dose rosuvastatin
      therapy 10mg/day, the changes of relative mean transit time (MTT) by CTP after rosuvastatin
      20mg/d treatment for 52 weeks (3) Compared with standard dose rosuvastatin therapy 10mg/day,
      the changes of lipid parameters (LDL-C, HDL-C, TG(Triglyceride), TC(Total Cholesterol), Apo A
      and Apo B ) after rosuvastatin 20mg/d for 52 weeks (4) Safety.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): standard or intensive dose rosuvastatin therapy based on other routine medication for stroke for 52 weeks.
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atherosclerotic Intracranial Arterial Stenosis; Intensive Rosuvastatin Therapy; Computed Tomography Perfusion (CTP)