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Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease (Challenge)

Primary Purpose

Cerebral Small Vessel Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
aspirin
cilostazol
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Small Vessel Disease focused on measuring Cerebral small vessel disease, Leukoaraiosis, Magnetic Resonance Imaging, Diffusion Tensor Imaging

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50 to 85 years of age
  • He/She can walk to the hospital (walker or cane is permissible).

  • Cerebral small vessel disease is observed on brain MRI.

    1) presence of one or more lacunar infarction and 2) moderate or severe confluent leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs >10 mm in maximum diameter

  • written informed consent

Exclusion Criteria:

  • Any patient with contraindication of antiplatelets
  • Any patient with cardioembolic source
  • Carotid bruit or large cerebral artery stenosis >50%
  • Cortical infarction or subcortical infarction lager than 1.5 cm
  • bleeding tendency
  • chronic liver disease (AST or ALT >100 IL/L)
  • chronic renal disease (Creatinine >3.0mg/dL)
  • active gastrointestinal ulcer
  • any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma)
  • Anemia (Hb <10g/dL) or thrombocytopenia
  • Cardiac pacemaker or contraindication to MRI
  • Pregnancy or breast-feeding
  • drug or alcohol addiction
  • Any other white matte disease (i.e., Multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor
  • Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease
  • any hearing or visual impairment that can disturb the efficient evaluation of the patient
  • recent cerebral infarction with 3 months

Sites / Locations

  • Myongji Hospital
  • National Health Insurance Corporation Ilsan Hospital
  • Dongtan Sacred Heart Hospital, Hallym University College of Medicine
  • Wonkwang University Iksan Hospital
  • Hallym University Medical Center
  • Bucheon St.Mary's Hospital
  • Soonchunhyang University Bucheon Hospital
  • Eulji University School of Medicine
  • Konyang University Hospital
  • Chonnam National University Hospital
  • Inha University Hospital
  • Gachon University Gil Medical
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Asan Medical Center
  • Chungang University Hospital
  • Ewha Womans University Mokdong Hospital
  • Kyung Hee University Hospital
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

aspirin

Cilostazol

Arm Description

aspirin 100mg by mouth once a day for 104 weeks

Pletaal SR 200mg by mouth once a day for 104 weeks

Outcomes

Primary Outcome Measures

Volume of white matter changes (WMCs)
Measure change of WMC on brain MRI

Secondary Outcome Measures

Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging
High MD and low FA means tissue damage.
Number of lacunes
High number means tissue damage.
number of microbleeds
High number means tissue damage.
brain volume and cortical thickness
Low score means tissue damage.
Mini-Mental State Examination
Measure global cognition. Score range is 0-30. Higher score means good cognition.
Neurocognitive test
Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test
Clinical Dementia Rating scale-sum of boxes
Measure global cognition. Score range is 0-18. Higher score means good cognition.
King's Health Questionnaire
Measure voiding function. Higher score means bad function.
Geriatric Depression Scale-Short form
Measure depression. Score range is 0-15. Higher score means depression.
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.
Bayer Activities of Daily Living
Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
Barthel Index
Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
Pyramidal and Extrapyramidal Scale (PEPS)
Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
Timed UP and Go (TUG) test
Measure gait. Higher score means bad gait.
Adverse event
measure any adverse events

Full Information

First Posted
August 27, 2013
Last Updated
August 6, 2019
Sponsor
Inha University Hospital
Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01932203
Brief Title
Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
Acronym
Challenge
Official Title
A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2013 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
Detailed Description
The primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease. The secondary objectives are to compare the impact of aspirin and cilostazol on DTI parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living. We also investigate risk factors associated with progression of cerebral small vessel disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Small Vessel Disease
Keywords
Cerebral small vessel disease, Leukoaraiosis, Magnetic Resonance Imaging, Diffusion Tensor Imaging

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
aspirin
Arm Type
Active Comparator
Arm Description
aspirin 100mg by mouth once a day for 104 weeks
Arm Title
Cilostazol
Arm Type
Experimental
Arm Description
Pletaal SR 200mg by mouth once a day for 104 weeks
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
100mg once a day
Intervention Type
Drug
Intervention Name(s)
cilostazol
Other Intervention Name(s)
Pletaal SR
Intervention Description
200mg once a day
Primary Outcome Measure Information:
Title
Volume of white matter changes (WMCs)
Description
Measure change of WMC on brain MRI
Time Frame
baseline, week 104
Secondary Outcome Measure Information:
Title
Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging
Description
High MD and low FA means tissue damage.
Time Frame
baseline and week 104
Title
Number of lacunes
Description
High number means tissue damage.
Time Frame
baseline and week 104
Title
number of microbleeds
Description
High number means tissue damage.
Time Frame
baseline and week 104
Title
brain volume and cortical thickness
Description
Low score means tissue damage.
Time Frame
baseline and week 104
Title
Mini-Mental State Examination
Description
Measure global cognition. Score range is 0-30. Higher score means good cognition.
Time Frame
baseline, week 52, and week 104
Title
Neurocognitive test
Description
Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test
Time Frame
baseline, week 52, and week 104
Title
Clinical Dementia Rating scale-sum of boxes
Description
Measure global cognition. Score range is 0-18. Higher score means good cognition.
Time Frame
baseline, week 52, and week 104
Title
King's Health Questionnaire
Description
Measure voiding function. Higher score means bad function.
Time Frame
baseline, week 42, and week 104
Title
Geriatric Depression Scale-Short form
Description
Measure depression. Score range is 0-15. Higher score means depression.
Time Frame
baseline, week 52, and week 104
Title
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Description
Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.
Time Frame
baseline, week 52, and week 104
Title
Bayer Activities of Daily Living
Description
Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
Time Frame
baseline, week 52, and week 104
Title
Barthel Index
Description
Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
Time Frame
baseline, week 52, and week 104
Title
Pyramidal and Extrapyramidal Scale (PEPS)
Description
Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
Time Frame
baseline, week 52, and week 104
Title
Timed UP and Go (TUG) test
Description
Measure gait. Higher score means bad gait.
Time Frame
basline, week 52, and week 104
Title
Adverse event
Description
measure any adverse events
Time Frame
baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104
Other Pre-specified Outcome Measures:
Title
All ischemic stroke event
Description
cerebral infarction and transient ischemic attack
Time Frame
week 104
Title
All vascular events
Description
including ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, cerebral venous thrombosis, pulmonary embolism, symptomatic deep vein thrombosis, symptomatic peripheral artery occlusion, other vascular occlusion, and any revascularization procedure
Time Frame
week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 to 85 years of age He/She can walk to the hospital (walker or cane is permissible). Cerebral small vessel disease is observed on brain MRI. 1) presence of one or more lacunar infarction and 2) moderate or severe confluent leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs >10 mm in maximum diameter written informed consent Exclusion Criteria: Any patient with contraindication of antiplatelets Any patient with cardioembolic source Carotid bruit or large cerebral artery stenosis >50% Cortical infarction or subcortical infarction lager than 1.5 cm bleeding tendency chronic liver disease (AST or ALT >100 IL/L) chronic renal disease (Creatinine >3.0mg/dL) active gastrointestinal ulcer any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma) Anemia (Hb <10g/dL) or thrombocytopenia Cardiac pacemaker or contraindication to MRI Pregnancy or breast-feeding drug or alcohol addiction Any other white matte disease (i.e., Multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease any hearing or visual impairment that can disturb the efficient evaluation of the patient recent cerebral infarction with 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Hye Choi, MD, PhD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myongji Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
412-270
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
City
Hwaseong-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Wonkwang University Iksan Hospital
City
Iksan
State/Province
Jeollabuk-do
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Bucheon St.Mary's Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Eulji University School of Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical
City
Incheon
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chungang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35833913
Citation
Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.
Results Reference
derived
PubMed Identifier
34781708
Citation
Kim BC, Youn YC, Jeong JH, Han HJ, Kim JH, Lee JH, Park KH, Park KW, Kim EJ, Oh MS, Shim Y, Lee JM, Choi YH, Park G, Kim S, Park HY, Yoon B, Yoon SJ, Cho SJ, Park KC, Na DL, Park SA, Choi SH. Cilostazol Versus Aspirin on White Matter Changes in Cerebral Small Vessel Disease: A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):698-709. doi: 10.1161/STROKEAHA.121.035766. Epub 2021 Nov 16.
Results Reference
derived
PubMed Identifier
31942173
Citation
Han HJ, Kim BC, Youn YC, Jeong JH, Kim JH, Lee JH, Park KH, Park KW, Kim EJ, Oh MS, Shim YS, Park HY, Yoon B, Yoon SJ, Cho SJ, Park KC, Na DL, Park SA, Lee JM, Choi SH. A Comparison Study of Cilostazol and Aspirin on Changes in Volume of Cerebral Small Vessel Disease White Matter Changes: Protocol of a Multicenter, Randomized Controlled Trial. Dement Neurocogn Disord. 2019 Dec;18(4):138-148. doi: 10.12779/dnd.2019.18.4.138. Epub 2019 Dec 13.
Results Reference
derived

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Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease

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