Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
Condition: Cerebral Infarction; Atherosclerosis
MeSH terms: Cerebral Infarction; Atherosclerosis; Infarction; Constriction, Pathologic
Intervention: clopidogrel; Cilostazol
Intervention description: Clopidogrel 75mg once a day plus placebo of cilostazol twice a day; Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
Intervention MeSH terms: Cilostazol; Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 457.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Infarction, Cerebral; cilostazol; stenosis; atherosclerosis; clopidogrel

Summary:

      This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1
      segment of Middle cerebral artery (MCA) or basilar artery).

      They will be randomly assigned into cilostazol group or clopidogrel group. Every patients
      will take 100mg of aspirin a day additionally.

      The primary outcome variable of this study is Progression rate of symptomatic intracranial
      stenosis on magnetic resonance angiogram (MRA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute
             ischemic brain lesions on MRI within 2 weeks from the onset

          -  Age: more than 35 years of age

          -  Patient with significant focal stenosis in the M1 segment of middle cerebral artery
             (MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging
             (MRI) within the vascular territory of the stenosed artery.

        Exclusion Criteria:

          -  Patients with any contraindications to the treatment with antiplatelet therapy

          -  Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation,
             atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left
             ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular
             segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse,
             mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis,
             congestive heart failure, recent myocardial infarction (within 4 weeks)

          -  Patients with more than 50% stenosis in the parent artery of symptomatic stenosis

          -  Bleeding diathesis

          -  Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine >
             3.0mg/dl)

          -  Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than
             100,000/mm3)

          -  Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting
             arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated
             angiopathy, and other vasculitis.

          -  Severe stroke: NIH stroke scale : more than 16

          -  Pregnant or lactating patients

          -  Chronic user of NSAIDs

          -  Thrombolytic therapy for the symptomatic stenosis

          -  Symptomatic stenosis scheduled for angioplasty

          -  Patients with pacemaker or any other contraindications to MRI