Brain Ischemia | PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage
Brain Ischemia research study
What is the primary objective of this study?
Through this study, the investigators are to prove that Cilostazol effectively prevent cardiovascular events in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects. The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the risk of cerebral hemorrhage without increase of cardiovascular events compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage. This study will prove the superiority of cilostazol on the prevention of cerebral hemorrhagic events without increasing the cardiovascular events against aspirin and the superiority of probucol on the prevention of overall cardiovascular events.
Who is eligible to participate?
Inclusion Criteria: - Patients with transient ischemic attack (TIA) or ischemic stroke within 180 days prior to screening - Adult aged 20 years or older - High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage) - Informed consent Exclusion Criteria: - Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks - Bleeding tendency - Pregnant or breast-feeding woman - Hemorrhagic stroke within 6 months - Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication - Severe cardiovascular disease such as cardiomyopathy or congestive heart failure - Life expectancy less than one year - Contraindication to long term aspirin use - Enrolled in other clinical trial within 30 days
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:CilostazolCilostazol 100mg bid
Drug:ProbucolProbucol 250mg bid
Drug:AspirinAspirin 100mg qd
Drug:placebo of cilostazolsame shape and size of active cilostazol
Drug:placebo of aspirinsame size and shape of active aspirin 100mg
Device:ankle-brachial index (ABI)measurement of ABI every years during follow up
Device:intima-medial thickness (IMT)ultrasound measured IMT of both common carotid arteries
Device:new asymptomatic brain hemorrhageasymptomatic macrobleedings or microbleedings on GRE images
Device:new ischemic lesions on follow-up FLAIR imagesany new ischemic lesions
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Cilostazol+ Probucol100mg cilostazol bid plus probucol plus placebo of aspirin
Aspirin + Probucolaspirin plus placebo cilostazol plus probucol
Cilostazolcilostazol plus placebo of aspirin
Aspirinaspirin plus placebo of cilostazol
Start Date: June 2009
Completed Date: December 2016
Phase: Phase 4
Primary Outcome: Time to the first occurrence of cerebral hemorrhage
Secondary Outcome: Time to the first occurrence of stroke
Study sponsors, principal investigator, and references
Principal Investigator: Sun U. Kwon, MD, PhD
Lead Sponsor: Asan Medical Center
Collaborator: Korea Otsuka Pharmaceutical Co., Ltd.