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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

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: Intima-medial thickness
    • ultrasound measured IMT of both common carotid arteries

Arms, Groups and Cohorts

  • Experimental: Cilostazol+ Probucol
    • 100mg cilostazol bid plus probucol plus placebo of aspirin
  • Active Comparator: Aspirin + Probucol
    • aspirin plus placebo cilostazol plus probucol
  • Experimental: Cilostazol
    • cilostazol plus placebo of aspirin
  • Active Comparator: Aspirin
    • aspirin plus placebo of cilostazol

Clinical Trial Outcome Measures

Primary Measures

  • mean carotid IMT progression
    • Time Frame: one year
    • Annualized rate of change in mean common carotid intimal-medial thickness

Secondary Measures

  • maximum carotid IMT progression
    • Time Frame: one year
    • annualized rate of change in maximal carotid intimal-medial thickness
  • carotid plaque score
    • Time Frame: one year
    • annualized change of carotid plaque score

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Collaborator
    • Korea Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sun U. Kwon, Professor – Asan Medical Center
  • Overall Official(s)
    • Sun U Kwon, MD,PhD, Principal Investigator, Department of Neurology, Asan Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.