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 (PICASSO)

NCT01013532 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Asan Medical Center
Phase	Phase 4
Status	UNKNOWN
Enrolment	1600
Start date	2009-06
Completion	2016-12

Conditions

• Brain Ischemia
• Intracranial Hemorrhages

Interventions

• Cilostazol
• Probucol
• Aspirin
• placebo of cilostazol
• placebo of aspirin
• ankle-brachial index (ABI)
• intima-medial thickness (IMT)
• new asymptomatic brain hemorrhage
• new ischemic lesions on follow-up FLAIR images

Primary outcomes

• Time to the first occurrence of cerebral hemorrhage — time since randomization; follow-up period is 1.0 to 5.5 years
• Time to the first occurence of composite cardiovascular events — time since randomization; follow-up period is 1.0 to 5.5 years

Countries

China, Philippines, South Korea