NCT02483169

PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study

Double Blind Placebo Controlled Multicenter Trial for Prevention of IMT Progression in the Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage With Cilostazol and Probucol

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness 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 progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.

Conditions

• Brain Ischemia
• Intracranial Hemorrhages

Interventions

Type	Name	Description
DRUG	cilostazol	Cilostazol 100mg bid
DRUG	Probucol	Probucol 250mg bid
DRUG	Aspirin	Aspirin 100mg qd
DRUG	placebo of cilostazol	same shape and size of active cilostazol
DRUG	Placebo of aspirin	same size and shape of active aspirin 100mg
DEVICE	Intima-medial thickness	ultrasound measured IMT of both common carotid arteries

Timeline

• Start date: 2009-06-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2015-06-26
• Last updated: 2015-12-24