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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Aspirin
  • Asprin (100mg) plus placebo
• Drug: cilostazol
  • Aspirin (100mg) plus cilostazol (200mg)

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Asprin (100mg) plus placebo
  • Asprin (100mg) plus placebo
• Active Comparator: Asprin (100mg) plus cilostazol (200mg)
  • Asprin (100mg) plus cilostazol (200mg)

Primary Measures

• 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
  • Time Frame: 14 days and 90 days from the baseline TCD study
    Safety Issue?: No

Secondary Measures

• Number of Patients With First Recurrent Stroke of Any Type
  • Time Frame: 90 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Inje University Other

Overall Clinical Trial Officials and Contacts

Jae Hyeon Park, MD, PhD Principal Investigator Sanggye Paik Hospital, Inje University College of Medicine  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00741286

Study ID Number: ECLIPse

ClinicalTrials.gov Identifier: NCT00741286

Health Authority: Korea: Food and Drug Administration