NCT00741286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 5, 2011

Completed
Last Updated

September 5, 2011

Status Verified

August 1, 2010

Enrollment Period

1.9 years

First QC Date

August 25, 2008

Results QC Date

August 3, 2010

Last Update Submit

August 4, 2011

Conditions

Cerebral Infarction

Keywords

Cerebral infarctionCilostazolAspirinTranscranial DopplerPulsatile Index

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Patients With First Recurrent Stroke of Any Type

    90 days

Study Arms (2)

Asprin (100mg) plus placebo

PLACEBO COMPARATOR

Asprin (100mg) plus placebo

Drug: Aspirin

Asprin (100mg) plus cilostazol (200mg)

ACTIVE COMPARATOR

Asprin (100mg) plus cilostazol (200mg)

Drug: cilostazol

Interventions

AspirinDRUG

Asprin (100mg) plus placebo

Asprin (100mg) plus placebo
cilostazolDRUG

Aspirin (100mg) plus cilostazol (200mg)

Also known as: Pletaal
Asprin (100mg) plus cilostazol (200mg)

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with first ever lacunar infarction within 7 days after the onset of symptoms
  • Age: more than 45 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sanbon Medical Center

Gunpo, 435-040, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Ilsan, 411-719, South Korea

Location

Bundang CHA Hospital

Seongnam, 463-712, South Korea

Location

National medical center

Seoul, 100-799, South Korea

Location

Yongdong Severance Hospital

Seoul, 135-720, South Korea

Location

Sanggye Paik Hospital

Seoul, 139-707, South Korea

Location

Ajou University Hospital

Suwon, 443-721, South Korea

Location

Wonju Christian Hospital

Wŏnju, 220-701, South Korea

Location

Related Publications (1)

  • Han SW, Lee SS, Kim SH, Lee JH, Kim GS, Kim OJ, Koh IS, Lee JY, Suk SH, Lee SI, Nam HS, Kim WJ, Yong SW, Lee KY, Park JH. Effect of cilostazol in acute lacunar infarction based on pulsatility index of transcranial Doppler (ECLIPse): a multicenter, randomized, double-blind, placebo-controlled trial. Eur Neurol. 2013;69(1):33-40. doi: 10.1159/000338247. Epub 2012 Nov 1.

    PMID: 23128968DERIVED

MeSH Terms

Conditions

Cerebral Infarction

Interventions

AspirinCilostazol

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Sang Won Han
Organization
Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
swhan@paik.ac.kr
82-2-950-8864

Study Officials

  • Jae Hyeon Park, MD, PhD

    Sanggye Paik Hospital, Inje University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

November 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 5, 2011

Results First Posted

September 5, 2011

Record last verified: 2010-08

Locations

KR(8)