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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

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.


Condition or disease Intervention/treatment Phase
Brain Ischemia Intracranial Hemorrhages Drug: cilostazol Drug: Probucol Drug: Aspirin Drug: placebo of cilostazol Drug: Placebo of aspirin Device: Intima-medial thickness Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2009
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
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: 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

Active Comparator: Aspirin + Probucol
aspirin plus placebo cilostazol plus probucol
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

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

Experimental: Cilostazol
cilostazol plus placebo of aspirin
Drug: cilostazol
Cilostazol 100mg bid
Other Name: Pletaal produced by Korea Otsuka Pharmaceutical company

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

Active Comparator: Aspirin
aspirin plus placebo of cilostazol
Drug: Aspirin
Aspirin 100mg qd

Drug: placebo of cilostazol
same shape and size of active cilostazol

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




Primary Outcome Measures :
  1. mean carotid IMT progression [ Time Frame: one year ]
    Annualized rate of change in mean common carotid intimal-medial thickness


Secondary Outcome Measures :
  1. maximum carotid IMT progression [ Time Frame: one year ]
    annualized rate of change in maximal carotid intimal-medial thickness

  2. carotid plaque score [ Time Frame: one year ]
    annualized change of carotid plaque score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483169


Sponsors and Collaborators
Asan Medical Center
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Sun U Kwon, MD,PhD Department of Neurology, Asan Medical Center
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Responsible Party: Sun U. Kwon, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02483169    
Other Study ID Numbers: PICASSO-IMT
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Keywords provided by Sun U. Kwon, Asan Medical Center:
ischemic stroke
intracranial hemorrhage
cilostazol
probucol
intima media thickness
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Brain Ischemia
Cerebral Hemorrhage
Ischemia
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Cilostazol
Probucol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics