NCT01932203

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
255

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_4

Geographic Reach
1 country

19 active sites

Status
unknown

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

July 17, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

6.1 years

First QC Date

August 27, 2013

Last Update Submit

August 6, 2019

Conditions

Cerebral Small Vessel Disease

Keywords

Cerebral small vessel diseaseLeukoaraiosisMagnetic Resonance ImagingDiffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

  • Volume of white matter changes (WMCs)

    Measure change of WMC on brain MRI

    baseline, week 104

Secondary Outcomes (15)

  • Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging

    baseline and week 104

  • Number of lacunes

    baseline and week 104

  • number of microbleeds

    baseline and week 104

  • brain volume and cortical thickness

    baseline and week 104

  • Mini-Mental State Examination

    baseline, week 52, and week 104

  • +10 more secondary outcomes

Other Outcomes (2)

  • All ischemic stroke event

    week 104

  • All vascular events

    week 104

Study Arms (2)

aspirin

ACTIVE COMPARATOR

aspirin 100mg by mouth once a day for 104 weeks

Drug: aspirin

Cilostazol

EXPERIMENTAL

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

Drug: cilostazol

Interventions

aspirinDRUG

100mg once a day

aspirin
cilostazolDRUG

200mg once a day

Also known as: Pletaal SR
Cilostazol

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \) 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Myongji Hospital

Goyang-si, Gyeonggi-do, 412-270, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

Dongtan Sacred Heart Hospital, Hallym University College of Medicine

Hwaseong-si, Gyeonggi-do, South Korea

Location

Wonkwang University Iksan Hospital

Iksan, Jeollabuk-do, South Korea

Location

Hallym University Medical Center

Anyang, South Korea

Location

Bucheon St.Mary's Hospital

Bucheon-si, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Eulji University School of Medicine

Daejeon, South Korea

Location

Konyang University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Gachon University Gil Medical

Incheon, South Korea

Location

Dong-A University Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chungang University Hospital

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 35833913DERIVED

  • 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.

    PMID: 34781708DERIVED

  • 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.

    PMID: 31942173DERIVED

MeSH Terms

Conditions

Cerebral Small Vessel DiseasesLeukoaraiosis

Interventions

AspirinCilostazol

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Seong Hye Choi, MD, PhD

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

July 17, 2013

Primary Completion

August 6, 2019

Study Completion

August 31, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

KR(19)