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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02483169
Other study ID # PICASSO-IMT
Secondary ID
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


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
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