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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483169
Recruitment Status : Unknown
Verified December 2015 by Sun U. Kwon, Asan Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : December 24, 2015
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Sun U. Kwon, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE June 24, 2015
First Posted Date  ICMJE June 26, 2015
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
mean carotid IMT progression [ Time Frame: one year ]
Annualized rate of change in mean common carotid intimal-medial thickness
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Ischemia
  • Intracranial Hemorrhages
Intervention  ICMJE
  • Drug: cilostazol
    Cilostazol 100mg bid
    Other Name: Pletaal produced by Korea Otsuka Pharmaceutical company
  • Drug: Probucol
    Probucol 250mg bid
    Other Name: Probucol is produced by Otsuka Pharmaceutical
  • 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
    Other Names:
    • - Annualized change of mean and maximum common carotid intima-medial thickness
    • - Annualized change of carotid plaque score
Study Arms  ICMJE
  • Experimental: Cilostazol+ Probucol
    100mg cilostazol bid plus probucol plus placebo of aspirin
    Interventions:
    • Drug: cilostazol
    • Drug: Probucol
    • Drug: Placebo of aspirin
    • Device: Intima-medial thickness
  • Active Comparator: Aspirin + Probucol
    aspirin plus placebo cilostazol plus probucol
    Interventions:
    • Drug: Probucol
    • Drug: Aspirin
    • Drug: placebo of cilostazol
    • Device: Intima-medial thickness
  • Experimental: Cilostazol
    cilostazol plus placebo of aspirin
    Interventions:
    • Drug: cilostazol
    • Drug: Placebo of aspirin
    • Device: Intima-medial thickness
  • Active Comparator: Aspirin
    aspirin plus placebo of cilostazol
    Interventions:
    • Drug: Aspirin
    • Drug: placebo of cilostazol
    • Device: Intima-medial thickness
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 25, 2015)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483169
Other Study ID Numbers  ICMJE PICASSO-IMT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun U. Kwon, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Korea Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Sun U Kwon, MD,PhD Department of Neurology, Asan Medical Center
PRS Account Asan Medical Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP