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

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin
cilostazol
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring Cerebral infarction, Cilostazol, Aspirin, Transcranial Doppler, Pulsatile Index

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanbon Medical Center
  • National Health Insurance Corporation Ilsan Hospital
  • Bundang CHA Hospital
  • National medical center
  • Yongdong Severance Hospital
  • Sanggye Paik Hospital
  • Ajou University Hospital
  • Wonju Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Asprin (100mg) plus placebo

Asprin (100mg) plus cilostazol (200mg)

Arm Description

Asprin (100mg) plus placebo

Asprin (100mg) plus cilostazol (200mg)

Outcomes

Primary Outcome 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
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

Number of Patients With First Recurrent Stroke of Any Type

Full Information

First Posted
August 25, 2008
Last Updated
August 4, 2011
Sponsor
Inje University
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00741286
Brief Title
Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Inje University
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
Cerebral infarction, Cilostazol, Aspirin, Transcranial Doppler, Pulsatile Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asprin (100mg) plus placebo
Arm Type
Placebo Comparator
Arm Description
Asprin (100mg) plus placebo
Arm Title
Asprin (100mg) plus cilostazol (200mg)
Arm Type
Active Comparator
Arm Description
Asprin (100mg) plus cilostazol (200mg)
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Asprin (100mg) plus placebo
Intervention Type
Drug
Intervention Name(s)
cilostazol
Other Intervention Name(s)
Pletaal
Intervention Description
Aspirin (100mg) plus cilostazol (200mg)
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
14 days and 90 days from the baseline TCD study
Secondary Outcome Measure Information:
Title
Number of Patients With First Recurrent Stroke of Any Type
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hyeon Park, MD, PhD
Organizational Affiliation
Sanggye Paik Hospital, Inje University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanbon Medical Center
City
Gunpo
ZIP/Postal Code
435-040
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation Ilsan Hospital
City
Ilsan
ZIP/Postal Code
411-719
Country
Korea, Republic of
Facility Name
Bundang CHA Hospital
City
Seongnam
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
National medical center
City
Seoul
ZIP/Postal Code
100-799
Country
Korea, Republic of
Facility Name
Yongdong Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23128968
Citation
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.
Results Reference
derived

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

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