NCT00741286

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cerebral Infarction

Interventions

Type	Name	Description
DRUG	Aspirin	Asprin (100mg) plus placebo
DRUG	cilostazol	Aspirin (100mg) plus cilostazol (200mg)

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-08-26
• Last updated: 2011-09-05
• Results posted: 2011-09-05

Locations

8 sites across 1 country: South Korea