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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?

Brain Ischemia

Intracranial Hemorrhages

Study Interventions

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

Study Arms

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

Study Status

Unknown status

Start Date: June 2009

Completed Date: December 2016

Phase: Phase 4

Type: Interventional

Design:

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.

More information:https://clinicaltrials.gov/show/NCT01013532

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