Clinical trial NCT01013532: PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage
Official title: A Multicenter, Double Blind, Factorial Design, Phase IV Trial to Compare the Efficacy and Safety of Cilostazol Long-term Treatment With Aspirin in Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage for the Prevention of Cerebral Hemorrhage and Cardiovascular Events and to Compare the Preventive Effect of Probucol in the Same Patient Group With Non-drug User Group for the Prevention of Cardiovascular Events
Conditions: Brain Ischemia
Intracranial Hemorrhages
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.
Interventions:
description: Cilostazol 100mg bid
name: Cilostazol
other_name: Pletaal produced by Korea Otsuka Pharmaceutical company
type: Drug
description: Probucol 250mg bid
name: Probucol
other_name: Probucol is produced by Otsuka Pharmaceutical
type: Drug
description: Aspirin 100mg qd
name: Aspirin
type: Drug
description: same shape and size of active cilostazol
name: placebo of cilostazol
type: Drug
description: same size and shape of active aspirin 100mg
name: placebo of aspirin
type: Drug
description: measurement of ABI every years during follow up
name: ankle-brachial index (ABI)
type: Device
description: ultrasound measured IMT of both common carotid arteries
name: intima-medial thickness (IMT)
other_name: change of maximal IMT and mean IMT
type: Device
description: asymptomatic macrobleedings or microbleedings on GRE images
name: new asymptomatic brain hemorrhage
type: Device
description: any new ischemic lesions
name: new ischemic lesions on follow-up FLAIR images
type: Device
Study arms:
design_group_description: 100mg cilostazol bid plus probucol plus placebo of aspirin
design_group_title: Cilostazol+ Probucol
design_group_type: Experimental
design_group_description: aspirin plus placebo cilostazol plus probucol
design_group_title: Aspirin + Probucol
design_group_type: Active Comparator
design_group_description: cilostazol plus placebo of aspirin
design_group_title: Cilostazol
design_group_type: Experimental
design_group_description: aspirin plus placebo of cilostazol
design_group_title: Aspirin
design_group_type: Active Comparator
Sponsor: Asan Medical Center
Collaborators: Korea Otsuka Pharmaceutical Co., Ltd.
Drug name mappings:
name: 普罗布考
lang: CN
name: Probucol
lang: EN
name: プロブコール
lang: JP
name: 西洛他唑
lang: CN
name: Cilostazol
lang: EN
name: シロスタゾール
lang: JP