Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Stroke, Lacunar; Infarction
Intervention: Aspirin; cilostazol
Intervention description: Asprin (100mg) plus placebo; Aspirin (100mg) plus cilostazol (200mg)
Intervention MeSH terms: Aspirin; Cilostazol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Cerebral infarction; Cilostazol; Aspirin; Transcranial Doppler; Pulsatile Index

Summary:

      RATIONALE:

        -  Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been
           postulated to reflect downstream increased vascular resistance caused by small-vessel
           disease (SVD).

        -  Small arterial vessels are a significant determinant of vascular resistance and PIs are
           elevated when SVD is present in the intracranial circulation.

        -  Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such
           as vasodilation and neuroprotective effect. It has been shown to be effective in the
           secondary prevention of stroke especially in the SVD and it may be related to the other
           non-antiplatelet effects of cilostazol.

      OBJECTIVES:

        -  In this study, we aim to investigate whether cilostazol affects the changes of PIs in
           patients with acute lacunar infarction using serial TCDs.

        -  Our hypothesis is that cilostazol has other non-antiplatelet effects such as
           vasodilation effect and may decrease the vascular resistance in patients with acute
           lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute
           lacunar infarction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with first ever lacunar infarction within 7 days after the onset of symptoms

          -  Age: more than 45 years of age

        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)

          -  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.

          -  Pregnant or lactating patients

          -  Patients with hyperthyroidism or COPD

          -  Patients with current anticoagulation or antiplatelet therapy

          -  Patients with poor temporal window in transcranial Doppler