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

Phase 4

Completed

• Conditions: Cerebral Infarction
• Interventions: Drug: cilostazol; Drug: Aspirin

• Registration Number: NCT00741286
• Lead Sponsor: Inje University

Brief 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2010-08
• Results First Submitted: 2010-08-03
• Results First Submitted QC: 2011-08-04
• Last Update Submitted: 2011-08-04
• Results First Posted: 2011-09-05
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asprin (100mg) plus cilostazol (200mg)	cilostazol	Asprin (100mg) plus cilostazol (200mg)
Asprin (100mg) plus placebo	Aspirin	Asprin (100mg) plus placebo

Primary Outcome Measures

Name	Time	Method
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	14 days and 90 days from the baseline 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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With First Recurrent Stroke of Any Type	90 days

Trial Locations

Locations (8)

Wonju Christian Hospital; 🇰🇷 Wonju, Korea, Republic of

Sanbon Medical Center; 🇰🇷 Gunpo, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Yongdong Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Bundang CHA Hospital; 🇰🇷 Seongnam, Korea, Republic of

National medical center; 🇰🇷 Seoul, Korea, Republic of