NCT00216749

Brief Summary

This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 17, 2009

Status Verified

December 1, 2009

Enrollment Period

3.8 years

First QC Date

September 14, 2005

Last Update Submit

December 15, 2009

Conditions

Cerebral Infarction

Keywords

Cerebral Infarction PreventionCilostazol

Outcome Measures

Primary Outcomes (1)

  • 1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event

    3M

Study Arms (1)

Cilostazol

Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in restabilization status after cerebral infarction (excluding cardiogenic cerebral embolism)

You may qualify if:

  • Patient with an experience of cerebral infarction and having a purpose for prevention of recurrence of cerebral infarction.
  • Age: more than 18 years of age

You may not qualify if:

  • Unqualified patients judged by study investigator(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Bo Youn Seo

    Korea Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

December 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

December 17, 2009

Record last verified: 2009-12

Locations

KR(1)