NCT02483169

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

7.3 years

First QC Date

June 24, 2015

Last Update Submit

December 23, 2015

Conditions

Brain IschemiaIntracranial Hemorrhages

Keywords

ischemic strokeintracranial hemorrhagecilostazolprobucolintima media thickness

Outcome Measures

Primary Outcomes (1)

  • mean carotid IMT progression

    Annualized rate of change in mean common carotid intimal-medial thickness

    one year

Secondary Outcomes (2)

  • maximum carotid IMT progression

    one year

  • carotid plaque score

    one year

Study Arms (4)

Cilostazol+ Probucol

EXPERIMENTAL

100mg cilostazol bid plus probucol plus placebo of aspirin

Drug: cilostazolDrug: ProbucolDrug: Placebo of aspirinDevice: Intima-medial thickness

Aspirin + Probucol

ACTIVE COMPARATOR

aspirin plus placebo cilostazol plus probucol

Drug: ProbucolDrug: AspirinDrug: placebo of cilostazolDevice: Intima-medial thickness

Cilostazol

EXPERIMENTAL

cilostazol plus placebo of aspirin

Drug: cilostazolDrug: Placebo of aspirinDevice: Intima-medial thickness

Aspirin

ACTIVE COMPARATOR

aspirin plus placebo of cilostazol

Drug: AspirinDrug: placebo of cilostazolDevice: Intima-medial thickness

Interventions

cilostazolDRUG

Cilostazol 100mg bid

Also known as: Pletaal produced by Korea Otsuka Pharmaceutical company
CilostazolCilostazol+ Probucol
ProbucolDRUG

Probucol 250mg bid

Also known as: Probucol is produced by Otsuka Pharmaceutical
Aspirin + ProbucolCilostazol+ Probucol
AspirinDRUG

Aspirin 100mg qd

AspirinAspirin + Probucol
placebo of cilostazolDRUG

same shape and size of active cilostazol

AspirinAspirin + Probucol
Placebo of aspirinDRUG

same size and shape of active aspirin 100mg

CilostazolCilostazol+ Probucol
Intima-medial thicknessDEVICE

ultrasound measured IMT of both common carotid arteries

Also known as: - Annualized change of mean and maximum common carotid intima-medial thickness, - Annualized change of carotid plaque score
AspirinAspirin + ProbucolCilostazolCilostazol+ Probucol

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain IschemiaIntracranial HemorrhagesIschemic Stroke

Interventions

CilostazolProbucolAspirin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsStroke

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSalicylatesHydroxybenzoates

Study Officials

  • Sun U Kwon, MD,PhD

    Department of Neurology, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 26, 2015

Study Start

June 1, 2009

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

December 24, 2015

Record last verified: 2015-12