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

Cerebral Infarction Clinical Trial

— ECLIPse  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741286
• Other study ID #: ECLIPse
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2008
• Last updated: August 4, 2011
• Start date: November 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2010
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Sanbon Medical Center	Gunpo
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Ilsan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	National medical center	Seoul
Korea, Republic of	Sanggye Paik Hospital	Seoul
Korea, Republic of	Yongdong Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Wonju Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days and 90 days from the baseline TCD study	No
Secondary	Number of Patients With First Recurrent Stroke of Any Type		90 days	No