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

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.

Conditions

• Brain Ischemia
• Intracranial Hemorrhages

Interventions

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

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 hemorrhage

asymptomatic macrobleedings or microbleedings on GRE images

DEVICE

new ischemic lesions on follow-up FLAIR images

any new ischemic lesions

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Asan Medical Center

  lead OTHER

Principal Investigators

• Sun U. Kwon, MD, PhD · Departement of Neurology, Asan Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2016-09-30

Completion

2016-12-31

Countries

• China
• Philippines
• South Korea

Study Locations