Cerebral InfarctionNCT00216749
Efficacy and Safety of Cilostazol for the Indication of CSPS
An observational study of Cerebral Infarction, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Infarction
- How many people
- 650 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2003to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in restabilization status after cerebral infarction (excluding cardiogenic cerebral embolism)
Who may be able to join
- 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
Who cannot join
- Unqualified patients judged by study investigator(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS
This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.
Read the detailed description
This is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction.
Qualified patients will be treated with cilostazol by physician's assessment. This study will be continued for 4 years. More than 600 patients for 4 years.
- Conditions
- Cerebral Infarction
- Keywords
- Cerebral Infarction Prevention, Cilostazol
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event
Measured: 3M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bo Youn Seo, Study director, Korea Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216749
- Sponsor's protocol ID
- Korea Pletaal CSPS PMS
- Status last verified
- Dec 2009
- First submitted
- 14 Sep 2005
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS
- ClinicalTrials.gov ID
- NCT00216749
- Acronym / sponsor ID
- Korea Pletaal CSPS PMS
- Conditions
- Cerebral Infarction
- Keywords
- Cerebral Infarction Prevention, Cilostazol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.
Detailed description
This is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction.
Qualified patients will be treated with cilostazol by physician's assessment. This study will be continued for 4 years. More than 600 patients for 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | – | –Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in restabilization status after cerebral infarction (excluding cardiogenic cerebral embolism)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unqualified patients judged by study investigator(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event
Time frame: 3M
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Youn Seo study director
Korea Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event (time frame: 3M). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2009.