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
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.
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 progressioncarotid plaque score
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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