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

Cerebral Infarction Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

• NCT number: NCT00741286
• Study type: Interventional
• Source: Inje University
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Completion date: October 2008