Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler

Study Overview
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Brief Summary
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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.

Detailed Description
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TREATMENTS: Cilostazol is an agent inhibiting platelet aggregation. A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet. TREATMENT PLAN: There will be two treatment groups; one will receive cilostazol 200mg (100mg twice per day), the second matching placebo of cilostazol. These study drugs will be administered on top of aspirin (100mg) systematically prescribed to such patients PRIMARY ENDPOINT: The changes of PI between the baseline and 14 and 90 days follow-up study. STUDY EXECUTION: Two hundred sixty patients, presenting with first ever lacunar infarction within 7 days after the onset of symptoms will be recruited within two years. Patients will be followed up during the three months.

Official Title
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Study for the Multi-Center Placebo-Controlled Double-Blind Clinical Trial for the Evaluation of the Effect of Cilostazol on Pulsatility Index of Transcranial Doppler in the Acute Lacunar Infarction Patients

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Drug: Aspirin
* Drug: cilostazol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Asprin (100mg) plus placebo<br>Asprin (100mg) plus placebo | Drug: Aspirin<br>* Asprin (100mg) plus placebo<br>|
| Active Comparator: Asprin (100mg) plus cilostazol (200mg)<br>Asprin (100mg) plus cilostazol (200mg) | Drug: cilostazol<br>* Aspirin (100mg) plus cilostazol (200mg)<br>* Other names: Pletaal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study | The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling's PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study. | 14 days and 90 days from the baseline TCD study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With First Recurrent Stroke of Any Type |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral infarction, Cilostazol, Aspirin, Transcranial Doppler, Pulsatile Index