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

August 6, 2019 updated by: Inha University Hospital

A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease

There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Hallym University Medical Center
      • Bucheon, Korea, Republic of
        • SoonChunHyang University Bucheon Hospital
      • Bucheon, Korea, Republic of
        • Bucheon St.Mary's Hospital
      • Daejeon, Korea, Republic of
        • Konyang University Hospital
      • Daejeon, Korea, Republic of
        • Eulji University School of Medicine
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Dong-A University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of
        • Chungang University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 412-270
        • Myongji Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • National Health Insurance Corporation Ilsan Hospital
      • Hwaseong-si, Gyeonggi-do, Korea, Republic of
        • Dongtan Sacred Heart Hospital, Hallym University College of Medicine
    • Jeollabuk-do
      • Iksan, Jeollabuk-do, Korea, Republic of
        • Wonkwang University Iksan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aspirin
aspirin 100mg by mouth once a day for 104 weeks
Drug: aspirin
100mg once a day
Experimental: Cilostazol
Pletaal SR 200mg by mouth once a day for 104 weeks
Drug: cilostazol
200mg once a day
Other Names:
  • Pletaal SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of white matter changes (WMCs)
Time Frame: baseline, week 104
Measure change of WMC on brain MRI
baseline, week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging
Time Frame: baseline and week 104
High MD and low FA means tissue damage.
baseline and week 104
Number of lacunes
Time Frame: baseline and week 104
High number means tissue damage.
baseline and week 104
number of microbleeds
Time Frame: baseline and week 104
High number means tissue damage.
baseline and week 104
brain volume and cortical thickness
Time Frame: baseline and week 104
Low score means tissue damage.
baseline and week 104
Mini-Mental State Examination
Time Frame: baseline, week 52, and week 104
Measure global cognition. Score range is 0-30. Higher score means good cognition.
baseline, week 52, and week 104
Neurocognitive test
Time Frame: baseline, week 52, and week 104
Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test
baseline, week 52, and week 104
Clinical Dementia Rating scale-sum of boxes
Time Frame: baseline, week 52, and week 104
Measure global cognition. Score range is 0-18. Higher score means good cognition.
baseline, week 52, and week 104
King's Health Questionnaire
Time Frame: baseline, week 42, and week 104
Measure voiding function. Higher score means bad function.
baseline, week 42, and week 104
Geriatric Depression Scale-Short form
Time Frame: baseline, week 52, and week 104
Measure depression. Score range is 0-15. Higher score means depression.
baseline, week 52, and week 104
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Time Frame: baseline, week 52, and week 104
Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.
baseline, week 52, and week 104
Bayer Activities of Daily Living
Time Frame: baseline, week 52, and week 104
Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
baseline, week 52, and week 104
Barthel Index
Time Frame: baseline, week 52, and week 104
Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
baseline, week 52, and week 104
Pyramidal and Extrapyramidal Scale (PEPS)
Time Frame: baseline, week 52, and week 104
Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
baseline, week 52, and week 104
Timed UP and Go (TUG) test
Time Frame: basline, week 52, and week 104
Measure gait. Higher score means bad gait.
basline, week 52, and week 104
Adverse event
Time Frame: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104
measure any adverse events
baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All ischemic stroke event
Time Frame: week 104
cerebral infarction and transient ischemic attack
week 104
All vascular events
Time Frame: week 104
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
week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

  • Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2013

Primary Completion (Actual)

August 6, 2019

Study Completion (Anticipated)

August 31, 2019

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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