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

Phase 4

• Conditions: Brain Ischemia; Intracranial Hemorrhages
• Interventions: Drug: cilostazol; Drug: Probucol; Drug: Aspirin; Drug: Placebo of aspirin; Drug: placebo of cilostazol; Device: Intima-medial thickness

• Registration Number: NCT02483169
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cilostazol+ Probucol	cilostazol	100mg cilostazol bid plus probucol plus placebo of aspirin
Cilostazol+ Probucol	Probucol	100mg cilostazol bid plus probucol plus placebo of aspirin
Cilostazol+ Probucol	Placebo of aspirin	100mg cilostazol bid plus probucol plus placebo of aspirin
Cilostazol+ Probucol	Intima-medial thickness	100mg cilostazol bid plus probucol plus placebo of aspirin
Aspirin + Probucol	Probucol	aspirin plus placebo cilostazol plus probucol
Aspirin + Probucol	Aspirin	aspirin plus placebo cilostazol plus probucol
Aspirin + Probucol	placebo of cilostazol	aspirin plus placebo cilostazol plus probucol
Aspirin + Probucol	Intima-medial thickness	aspirin plus placebo cilostazol plus probucol
Cilostazol	Intima-medial thickness	cilostazol plus placebo of aspirin
Aspirin	placebo of cilostazol	aspirin plus placebo of cilostazol
Aspirin	Intima-medial thickness	aspirin plus placebo of cilostazol
Cilostazol	Placebo of aspirin	cilostazol plus placebo of aspirin
Cilostazol	cilostazol	cilostazol plus placebo of aspirin
Aspirin	Aspirin	aspirin plus placebo of cilostazol

Primary Outcome Measures

Name	Time	Method
mean carotid IMT progression	one year	Annualized rate of change in mean common carotid intimal-medial thickness

Secondary Outcome Measures

Name	Time	Method
maximum carotid IMT progression	one year	annualized rate of change in maximal carotid intimal-medial thickness
carotid plaque score	one year	annualized change of carotid plaque score