Overview

PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage

Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Treatments:
Aspirin
Cilostazol
Probucol
Criteria
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