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

Primary Purpose

Brain Ischemia, Intracranial Hemorrhages

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cilostazol
Probucol
Aspirin
placebo of cilostazol
Placebo of aspirin
Intima-medial thickness
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Ischemia focused on measuring ischemic stroke, intracranial hemorrhage, cilostazol, probucol, intima media thickness

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Cilostazol+ Probucol

    Aspirin + Probucol

    Cilostazol

    Aspirin

    Arm Description

    100mg cilostazol bid plus probucol plus placebo of aspirin

    aspirin plus placebo cilostazol plus probucol

    cilostazol plus placebo of aspirin

    aspirin plus placebo of cilostazol

    Outcomes

    Primary Outcome Measures

    mean carotid IMT progression
    Annualized rate of change in mean common carotid intimal-medial thickness

    Secondary Outcome Measures

    maximum carotid IMT progression
    annualized rate of change in maximal carotid intimal-medial thickness
    carotid plaque score
    annualized change of carotid plaque score

    Full Information

    First Posted
    June 24, 2015
    Last Updated
    December 23, 2015
    Sponsor
    Asan Medical Center
    Collaborators
    Korea Otsuka Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02483169
    Brief Title
    PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
    Acronym
    PICASSO-IMT
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asan Medical Center
    Collaborators
    Korea Otsuka Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Ischemia, Intracranial Hemorrhages
    Keywords
    ischemic stroke, intracranial hemorrhage, cilostazol, probucol, intima media thickness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cilostazol+ Probucol
    Arm Type
    Experimental
    Arm Description
    100mg cilostazol bid plus probucol plus placebo of aspirin
    Arm Title
    Aspirin + Probucol
    Arm Type
    Active Comparator
    Arm Description
    aspirin plus placebo cilostazol plus probucol
    Arm Title
    Cilostazol
    Arm Type
    Experimental
    Arm Description
    cilostazol plus placebo of aspirin
    Arm Title
    Aspirin
    Arm Type
    Active Comparator
    Arm Description
    aspirin plus placebo of cilostazol
    Intervention Type
    Drug
    Intervention Name(s)
    cilostazol
    Other Intervention Name(s)
    Pletaal produced by Korea Otsuka Pharmaceutical company
    Intervention Description
    Cilostazol 100mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    Probucol
    Other Intervention Name(s)
    Probucol is produced by Otsuka Pharmaceutical
    Intervention Description
    Probucol 250mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Intervention Description
    Aspirin 100mg qd
    Intervention Type
    Drug
    Intervention Name(s)
    placebo of cilostazol
    Intervention Description
    same shape and size of active cilostazol
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo of aspirin
    Intervention Description
    same size and shape of active aspirin 100mg
    Intervention Type
    Device
    Intervention Name(s)
    Intima-medial thickness
    Other Intervention Name(s)
    - Annualized change of mean and maximum common carotid intima-medial thickness, - Annualized change of carotid plaque score
    Intervention Description
    ultrasound measured IMT of both common carotid arteries
    Primary Outcome Measure Information:
    Title
    mean carotid IMT progression
    Description
    Annualized rate of change in mean common carotid intimal-medial thickness
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    maximum carotid IMT progression
    Description
    annualized rate of change in maximal carotid intimal-medial thickness
    Time Frame
    one year
    Title
    carotid plaque score
    Description
    annualized change of carotid plaque score
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sun U Kwon, MD,PhD
    Organizational Affiliation
    Department of Neurology, Asan Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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