Cerebral Small Vessel DiseasePhase 4ChallengeNCT01932203
Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
A Phase 4 study testing aspirin and cilostazol in people with Cerebral Small Vessel Disease, run by Inha University Hospital at 19 sites in South Korea.
Trial summary
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cerebral Small Vessel Disease
- What is being tested?
- aspirin and cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 19 sitesSouth Korea
- Study dates
- 17 Jul 2013to 31 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Hallym University Medical Center
Anyang
Bucheon St.Mary's Hospital
Bucheon-si
Soonchunhyang University Bucheon Hospital
Bucheon-si
Eulji University School of Medicine
Daejeon
Konyang University Hospital
Daejeon
Myongji Hospital
Goyang-si, Gyeonggi-do, 412-270
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do
Chonnam National University Hospital
Gwangju
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-si, Gyeonggi-do
Wonkwang University Iksan Hospital
Iksan, Jeollabuk-do
Inha University Hospital
Incheon, 400-711
Gachon University Gil Medical
Incheon
Dong-A University Hospital
Pusan
Pusan National University Hospital
Pusan
Asan Medical Center
Seoul
Chungang University Hospital
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Kyung Hee University Hospital
Seoul
Samsung Medical Center
Seoul
About this study
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
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
Read the 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.
- Conditions
- Cerebral Small Vessel Disease
- Being tested
- aspirin, cilostazol
- Keywords
- Cerebral small vessel disease, Leukoaraiosis, Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Medical subject headings
- Cerebral Small Vessel Diseases, Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
100mg once a day
cilostazolDrug
Also called Pletaal SR
200mg once a day
| Study group | Role | What they receive |
|---|---|---|
| aspirin | Active comparator | aspirin 100mg by mouth once a day for 104 weeks Receives: Drug: aspirin |
| Cilostazol | Experimental | Pletaal SR 200mg by mouth once a day for 104 weeks Receives: Drug: cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of white matter changes (WMCs)
Measure change of WMC on brain MRI
Measured: baseline, week 104
Secondary outcomes (15)
Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging
High MD and low FA means tissue damage.
Measured: baseline and week 104
Number of lacunes
High number means tissue damage.
Measured: baseline and week 104
number of microbleeds
High number means tissue damage.
Measured: baseline and week 104
brain volume and cortical thickness
Low score means tissue damage.
Measured: baseline and week 104
Mini-Mental State Examination
Measure global cognition. Score range is 0-30. Higher score means good cognition.
Measured: baseline, week 52, and week 104
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
Measured: baseline, week 52, and week 104
Clinical Dementia Rating scale-sum of boxes
Measure global cognition. Score range is 0-18. Higher score means good cognition.
Measured: baseline, week 52, and week 104
King's Health Questionnaire
Measure voiding function. Higher score means bad function.
Measured: baseline, week 42, and week 104
Geriatric Depression Scale-Short form
Measure depression. Score range is 0-15. Higher score means depression.
Measured: baseline, week 52, and week 104
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.
Measured: baseline, week 52, and week 104
Bayer Activities of Daily Living
Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
Measured: baseline, week 52, and week 104
Barthel Index
Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
Measured: baseline, week 52, and week 104
Pyramidal and Extrapyramidal Scale (PEPS)
Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
Measured: baseline, week 52, and week 104
Timed UP and Go (TUG) test
Measure gait. Higher score means bad gait.
Measured: basline, week 52, and week 104
Adverse event
measure any adverse events
Measured: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start17 Jul 2013
- Primary completion6 Aug 2019
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inha University Hospital, Inha University Hospital
- Investigators
- Seong Hye Choi, MD, PhD, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932203
- Sponsor's protocol ID
- 20130006
- Acronym
- Challenge
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2013
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35833913Kim 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.
PubMed 34781708Han 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.
PubMed 31942173
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01932203
- Acronym / sponsor ID
- Challenge / 20130006
- Conditions
- Cerebral Small Vessel Disease
- Keywords
- Cerebral small vessel disease, Leukoaraiosis, Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 17 Jul 2013 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspirin | Active comparator | Drug: aspirinaspirin 100mg by mouth once a day for 104 weeks |
| Cilostazol | Experimental | Drug: cilostazolPletaal SR 200mg by mouth once a day for 104 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin100mg once a day | Drug | aspirin |
| cilostazolAlso: Pletaal SR200mg once a day | Drug | Cilostazol |
Primary outcome
Volume of white matter changes (WMCs)
Time frame: baseline, week 104
Measure change of WMC on brain MRI
15 secondary outcomes
Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging
Time frame: baseline and week 104
Number of lacunes
Time frame: baseline and week 104
number of microbleeds
Time frame: baseline and week 104
brain volume and cortical thickness
Time frame: baseline and week 104
Mini-Mental State Examination
Time frame: baseline, week 52, and week 104
Neurocognitive test
Time frame: baseline, week 52, and week 104
Clinical Dementia Rating scale-sum of boxes
Time frame: baseline, week 52, and week 104
King's Health Questionnaire
Time frame: baseline, week 42, and week 104
Geriatric Depression Scale-Short form
Time frame: baseline, week 52, and week 104
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Time frame: baseline, week 52, and week 104
Bayer Activities of Daily Living
Time frame: baseline, week 52, and week 104
Barthel Index
Time frame: baseline, week 52, and week 104
Pyramidal and Extrapyramidal Scale (PEPS)
Time frame: baseline, week 52, and week 104
Timed UP and Go (TUG) test
Time frame: basline, week 52, and week 104
Adverse event
Time frame: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 35833913Kwan 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.
- Derived from this study: PubMed 34781708Kim 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.
- Derived from this study: PubMed 31942173Han 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong Hye Choi, MD, PhD principal investigator
Inha University Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin and cilostazol in people with Cerebral Small Vessel Disease, run by Inha University Hospital at 19 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of white matter changes (WMCs) (time frame: baseline, week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932203, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.