Overview

This trial is active, not recruiting.

Conditions brain ischemia, intracranial hemorrhages
Treatments cilostazol, probucol, aspirin, placebo of cilostazol, placebo of aspirin, intima-medial thickness
Phase phase 4
Sponsor Asan Medical Center
Collaborator Korea Otsuka Pharmaceutical Co.,Ltd.
Start date June 2009
End date September 2016
Trial size 800 participants
Trial identifier NCT02483169, PICASSO-IMT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
100mg cilostazol bid plus probucol plus placebo of aspirin
cilostazol Pletaal produced by Korea Otsuka Pharmaceutical company
Cilostazol 100mg bid
probucol Probucol is produced by Otsuka Pharmaceutical
Probucol 250mg bid
placebo of aspirin
same size and shape of active aspirin 100mg
intima-medial thickness - Annualized change of mean and maximum common carotid intima-medial thickness
ultrasound measured IMT of both common carotid arteries
(Active Comparator)
aspirin plus placebo cilostazol plus probucol
probucol Probucol is produced by Otsuka Pharmaceutical
Probucol 250mg bid
aspirin
Aspirin 100mg qd
placebo of cilostazol
same shape and size of active cilostazol
intima-medial thickness - Annualized change of mean and maximum common carotid intima-medial thickness
ultrasound measured IMT of both common carotid arteries
(Experimental)
cilostazol plus placebo of aspirin
cilostazol Pletaal produced by Korea Otsuka Pharmaceutical company
Cilostazol 100mg bid
placebo of aspirin
same size and shape of active aspirin 100mg
intima-medial thickness - Annualized change of mean and maximum common carotid intima-medial thickness
ultrasound measured IMT of both common carotid arteries
(Active Comparator)
aspirin plus placebo of cilostazol
aspirin
Aspirin 100mg qd
placebo of cilostazol
same shape and size of active cilostazol
intima-medial thickness - Annualized change of mean and maximum common carotid intima-medial thickness
ultrasound measured IMT of both common carotid arteries

Primary Outcomes

Measure
mean carotid IMT progression
time frame: one year

Secondary Outcomes

Measure
maximum carotid IMT progression
time frame: one year
carotid plaque score
time frame: one year

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Principal investigator Sun U Kwon, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Asan Medical Center.