Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease (NCT01932203) | Clinical Trial Compass
UnknownPhase 4
Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
South Korea255 participantsStarted 2013-07-17
Plain-language summary
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.