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

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Brain Ischemia; Intracranial Hemorrhages

Treatments: Drug: placebo of cilostazol; Drug: cilostazol; Drug: Aspirin; Device: Intima-medial thickness; Drug: Probucol; Drug: Placebo of aspirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02483169

PICASSO-IMT

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of ischemic stroke within 120 days
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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800 participants in 4 patient groups

Cilostazol+ Probucol

Experimental group

Description:

100mg cilostazol bid plus probucol plus placebo of aspirin

Treatment:

Drug: Probucol

Device: Intima-medial thickness

Drug: Placebo of aspirin

Drug: cilostazol

Aspirin + Probucol

Active Comparator group

Description:

aspirin plus placebo cilostazol plus probucol

Treatment:

Drug: Aspirin

Drug: Probucol

Drug: placebo of cilostazol

Device: Intima-medial thickness

Cilostazol

Experimental group

Description:

cilostazol plus placebo of aspirin

Treatment:

Device: Intima-medial thickness

Drug: Placebo of aspirin

Drug: cilostazol

Aspirin

Active Comparator group

Description:

aspirin plus placebo of cilostazol

Treatment:

Drug: Aspirin

Drug: placebo of cilostazol

Device: Intima-medial thickness