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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
203
Asprin (100mg) plus placebo
Aspirin (100mg) plus cilostazol (200mg)
Sanbon Medical Center
Gunpo, South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea
Bundang CHA Hospital
Seongnam, South Korea
National medical center
Seoul, South Korea
Yongdong Severance Hospital
Seoul, South Korea
Sanggye Paik Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Wonju Christian Hospital
Wŏnju, South Korea
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.
Time frame: 14 days and 90 days from the baseline TCD study
Number of Patients With First Recurrent Stroke of Any Type
Time frame: 90 days
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