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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02483169

Acronym

PICASSO-IMT

Enrollment

800

Registered

2015-06-26

Start date

2009-06-30

Completion date

2016-12-31

Last updated

2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Ischemia, Intracranial Hemorrhages

Keywords

ischemic stroke, intracranial hemorrhage, cilostazol, probucol, intima media thickness

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.

Interventions

DRUGcilostazol

Cilostazol 100mg bid

DRUGProbucol

Probucol 250mg bid

DRUGAspirin

Aspirin 100mg qd

DRUGplacebo of cilostazol

same shape and size of active cilostazol

DRUGPlacebo of aspirin

same size and shape of active aspirin 100mg

DEVICEIntima-medial thickness

ultrasound measured IMT of both common carotid arteries

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026