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

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Ischemia; Intracranial Hemorrhages

Intervention: cilostazol (Drug); Probucol (Drug); Aspirin (Drug); placebo of cilostazol (Drug); Placebo of aspirin (Drug); Intima-medial thickness (Device)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Sun U Kwon, MD,PhD, Principal Investigator, Affiliation: Department of Neurology, Asan Medical Center


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: mean carotid IMT progression

Secondary outcome:

maximum carotid IMT progression

carotid plaque score


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: June 2009
Last updated: June 25, 2015

Page last updated: August 23, 2015

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