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

Brain Ischemia Clinical Trial

— PICASSO-IMT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02483169
• Other study ID #: PICASSO-IMT
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 24, 2015
• Last updated: December 23, 2015
• Start date: June 2009
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages

Intervention

Drug:
• cilostazol
Cilostazol 100mg bid
• Probucol
Probucol 250mg bid
• Aspirin
Aspirin 100mg qd
• placebo of cilostazol
same shape and size of active cilostazol
• Placebo of aspirin
same size and shape of active aspirin 100mg

Device:
• Intima-medial thickness
ultrasound measured IMT of both common carotid arteries

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Otsuka Pharmaceutical Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean carotid IMT progression	Annualized rate of change in mean common carotid intimal-medial thickness	one year	No
Secondary	maximum carotid IMT progression	annualized rate of change in maximal carotid intimal-medial thickness	one year	No
Secondary	carotid plaque score	annualized change of carotid plaque score	one year	No