Trial · NCT00234065
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
NCT00234065, Phase 4, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2011-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2). Trials, record NCT00234065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00234065
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
- NCT number
- NCT00234065
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,800 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Cerebral Infarction
- Interventions
- Cilostazol, Aspirin
- First posted
- 2005-10-06
- Last updated
- 2011-06-10
- Results first posted
- 2011-05-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numbers of Patients With First Occurence of Stroke | From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) | The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints. |
| Secondary | Number of Patients With First Recurrence of Cerebral Infarction | From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | |
| Secondary | Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints. |
| Secondary | Number of Deaths From Any Cause | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints. |
| Secondary | Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints. |
| Other | Number of Patients With First Occurrence of Haemorrhagic Event | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numbers of Patients With First Occurence of Stroke | From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) | Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria. | participants | NUMBER |
| SECONDARY | Number of Patients With First Recurrence of Cerebral Infarction | From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | participants | NUMBER | |
| SECONDARY | Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria. | participants | NUMBER |
| SECONDARY | Number of Deaths From Any Cause | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | participants | NUMBER | |
| SECONDARY | Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Patients With First Occurrence of Haemorrhagic Event | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numbers of Patients With First Occurence of Stroke | Cilostazol | 82 | participants | ||
| Numbers of Patients With First Occurence of Stroke | Aspirin | 119 | participants | ||
| Number of Patients With First Recurrence of Cerebral Infarction | Cilostazol | 72 | participants | ||
| Number of Patients With First Recurrence of Cerebral Infarction | Aspirin | 88 | participants | ||
| Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease | Cilostazol | 86 | participants | ||
| Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease | Aspirin | 103 | participants | ||
| Number of Deaths From Any Cause | Cilostazol | 13 | participants | ||
| Number of Deaths From Any Cause | Aspirin | 13 | participants | ||
| Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events | Cilostazol | 138 | participants | ||
| Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events | Aspirin | 186 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilostazol | 1,356 | |
| Overall Study | STARTED | Aspirin | 1,360 | |
| Overall Study | COMPLETED | Cilostazol | 881 | |
| Overall Study | COMPLETED | Aspirin | 1,004 | |
| Overall Study | NOT COMPLETED | Cilostazol | 475 | |
| Overall Study | NOT COMPLETED | Aspirin | 356 |
Source ClinicalTrials.gov
Adverse events740
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Cilostazol | 156 | 1,337 | |
| other | Palpitations | Cardiac disorders | Aspirin | 71 | 1,335 | |
| other | Tachycardia | Cardiac disorders | Cilostazol | 89 | 1,337 | |
| other | Tachycardia | Cardiac disorders | Aspirin | 21 | 1,335 | |
| other | Diarrhoea | Gastrointestinal disorders | Cilostazol | 164 | 1,337 | |
| other | Diarrhoea | Gastrointestinal disorders | Aspirin | 85 | 1,335 | |
| other | Constipation | Gastrointestinal disorders | Cilostazol | 110 | 1,337 | |
| other | Constipation | Gastrointestinal disorders | Aspirin | 155 | 1,335 | |
| other | Dental caries | Gastrointestinal disorders | Cilostazol | 93 | 1,337 | |
| other | Dental caries | Gastrointestinal disorders | Aspirin | 114 | 1,335 |
1 to 10 of 740Source ClinicalTrials.gov
See all 740 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilostazol | ||
| Total, all-cause mortality | Aspirin | ||
| Total, other adverse events | Cilostazol | 1,267 | 1,337 |
| Total, other adverse events | Aspirin | 1,260 | 1,335 |
| Total, serious adverse events | Cilostazol | 372 | 1,337 |
| Total, serious adverse events | Aspirin | 433 | 1,335 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20833591 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cilostazol vs Aspirin: Number of Patients With First Recurrence of Cerebral Infarction | Trial comparisons |
| Cilostazol vs Aspirin: Number of Patients With First Occurrence of Haemorrhagic Event | Trial comparisons |
| Cilostazol vs Aspirin: Numbers of Patients With First Occurence of Stroke | Trial comparisons |
| Cilostazol vs Aspirin: Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease | Trial comparisons |
| Cilostazol vs Aspirin: Number of Deaths From Any Cause | Trial comparisons |
| Cilostazol vs Aspirin: Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events | Trial comparisons |
| Cilostazol vs Aspirin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00234065
GET https://conductscience.org/api/trials/v1/NCT00234065/events?page=2