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Rationale and Design of the Prevention of Cardiovascular Events in Ischemic Stroke Patients with High Risk of Cerebral Hemorrhage (Picasso) Study: A Randomized Controlled Trial

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Author(s)
Keun-Sik HongBum Joon KimJun-Young LeeSun U. Kwon
Keimyung Author(s)
Sohn, Sung Il
Department
Dept. of Neurology (신경과학)
Journal Title
International Journal of Stroke
Issued Date
2015
Volume
10
Issue
7
Keyword
Cerebral infarctionCilostazolClinical trialIntracerebral haemorrhageMicrobleedsProbucol
Abstract
microbleeds may increase the risk of haemorrhagic stroke.
However, the optimal long-term antiplatelet therapy and lipid
management in these patients remain unclear.
Aim PreventIon of CArdiovascular events in iSchemic Stroke
patients with high risk of cerebral hemOrrhage was designed
to compare cilostazol and aspirin and to assess the effect of
adding probucol, a lipid-lowering and anti-oxidative agent, in
patients at high risk of haemorrhagic stroke.
Sample size estimate The projected sample size is 1600
patients with at least 12 months of follow-up.
Methods and design PreventIon of CArdiovascular events in
iSchemic Stroke patients with high risk of cerebral hemOrrhage
is a randomized trial involving 67 institutes from 3 countries.
Patients with non-cardioembolic ischemic stroke or
transient ischemic attack within 180 days and with prior intracerebral
haemorrhage or multiple cerebral microbleeds on gradient
echo imaging are eligible. Enrolled patients are
simultaneously randomized in a 2 × 2 factorial design: doubleblind
for cilostazol 200 mg/day vs. aspirin 100 mg/day, and an
open-label, blind end-point evaluation for probucol 500 mg/
day vs. non-probucol.
Study outcomes The co-primary end-points are the safety endpoint
of haemorrhagic stroke and the efficacy end-point of a
composite of stroke, myocardial infarction, or vascular death.
Time-to-event will be analyzed separately for each intervention:
superiority testing for the safety of cilostazol over aspirin
as well as the efficacy of probucol over non-probucol, and
non-inferiority testing for the efficacy of cilostazol to aspirin.
Discussion PreventIon of CArdiovascular events in iSchemic
Stroke patients with high risk of cerebral hemOrrhage is the
largest secondary stroke prevention trial for informing antiplatelet
therapy and lipid management in patients at high risk
of haemorrhagic stroke.
Keimyung Author(s)(Kor)
손성일
Publisher
School of Medicine
Citation
Keun-Sik Hong et al. (2015). Rationale and Design of the Prevention of Cardiovascular Events in Ischemic Stroke Patients with High Risk of Cerebral Hemorrhage (Picasso) Study: A Randomized Controlled Trial. International Journal of Stroke, 10(7), 1153–1158. doi: 10.1111/ijs.12519
Type
Article
ISSN
1747-4930
Source
http://journals.sagepub.com.proxy.dsmc.or.kr/doi/abs/10.1111/ijs.12519?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
DOI
10.1111/ijs.12519
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/33036
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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