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

NCT02483169 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2015-12-24

No results posted yet for this study

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.

Conditions

  • Brain Ischemia
  • Intracranial Hemorrhages

Interventions

DRUG

cilostazol

Cilostazol 100mg bid

DRUG

Probucol

Probucol 250mg bid

DRUG

Aspirin

Aspirin 100mg qd

DRUG

placebo of cilostazol

same shape and size of active cilostazol

DRUG

Placebo of aspirin

same size and shape of active aspirin 100mg

DEVICE

Intima-medial thickness

ultrasound measured IMT of both common carotid arteries

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Sun U Kwon, MD,PhD · Department of Neurology, Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2016-09-30
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02483169 on ClinicalTrials.gov