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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02483169

Collaborator

Korea Otsuka Pharmaceutical Co., Ltd. (Industry)

800

Enrollment

Arms

Duration (Months)

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cilostazol+ Probucol 100mg cilostazol bid plus probucol plus placebo of aspirin	Drug: cilostazol Cilostazol 100mg bid Other Names: Pletaal produced by Korea Otsuka Pharmaceutical company Drug: Probucol Probucol 250mg bid Other Names: 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 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

Outcome Measures

Primary Outcome Measures

mean carotid IMT progression [one year]
Annualized rate of change in mean common carotid intimal-medial thickness

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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