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

December 23, 2015 updated by: Sun U. Kwon, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
Drug: Probucol
Probucol 250mg bid
Other Names:
  • Probucol is produced by Otsuka Pharmaceutical
Drug: cilostazol
Cilostazol 100mg bid
Other Names:
  • 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 + Probucol
aspirin plus placebo cilostazol plus probucol
Drug: Probucol
Probucol 250mg bid
Other Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Sun U Kwon, MD,PhD, Department of Neurology, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

September 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (ESTIMATE)

June 26, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICASSO-IMT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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