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

NCT02483169 — Phase 4, Unknown, 800 participants, Asan Medical Center
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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

RegistryNCT02483169, acronym PICASSO-IMT
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, factorial, masking: quadruple, treatment
Enrollment800 (Estimated)
SponsorAsan Medical Center (Other); collaborators: Korea Otsuka Pharmaceutical Co., Ltd.
ConditionsBrain Ischemia, Intracranial Hemorrhages
Interventionscilostazol, Probucol, Aspirin, placebo of cilostazol, Placebo of aspirin, Intima-medial thickness (Drug, device)
Datesstart 2009-06-01, primary completion 2016-09-01 (estimated), completion 2016-12-01 (estimated), first posted 2015-06-26, last updated 2015-12-24

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Cilostazol+ ProbucolExperimentalDrug: cilostazol; Drug: Probucol; Drug: Placebo of aspirin; Device: Intima-medial thickness100mg cilostazol bid plus probucol plus placebo of aspirin
Aspirin + ProbucolActive comparatorDrug: Probucol; Drug: Aspirin; Drug: placebo of cilostazol; Device: Intima-medial thicknessaspirin plus placebo cilostazol plus probucol
CilostazolExperimentalDrug: cilostazol; Drug: Placebo of aspirin; Device: Intima-medial thicknesscilostazol plus placebo of aspirin
AspirinActive comparatorDrug: Aspirin; Drug: placebo of cilostazol; Device: Intima-medial thicknessaspirin plus placebo of cilostazol
  • cilostazol (Drug), also known as Pletaal produced by Korea Otsuka Pharmaceutical company: Cilostazol 100mg bid
  • Probucol (Drug), also known as Probucol is produced by Otsuka Pharmaceutical: Probucol 250mg bid
  • Aspirin (Drug): Aspirin 100mg qd
  • placebo of cilostazol (Drug): same shape and size of active cilostazol
  • Placebo of aspirin (Drug): same size and shape of active aspirin 100mg
  • Intima-medial thickness (Device), also known as - Annualized change of mean and maximum common carotid intima-medial thickness, - Annualized change of carotid plaque score: ultrasound measured IMT of both common carotid arteries

+Outcome measures

Primary outcomes

  • mean carotid IMT progression [one year]: Annualized rate of change in mean common carotid intimal-medial thickness

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 20 Years to any

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

+Investigators

My Notes