Trial · NCT00130039
Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
NCT00130039, Phase 4, Completed, Asan Medical Center; results first posted 2010-01-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II. Trials, record NCT00130039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00130039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
- NCT number
- NCT00130039
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 457 participants, actual
- Lead sponsor
- Asan Medical Center
- Conditions
- Cerebral Infarction, Atherosclerosis
- Interventions
- clopidogrel, Cilostazol
- First posted
- 2005-08-15
- Last updated
- 2010-01-12
- Results first posted
- 2010-01-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression of Symptomatic Intracranial Stenosis | 7 months after treatment | Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA. The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA. |
| Secondary | Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI | 7 months after treatment | number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI. |
| Secondary | Number of Participants With Stroke Events | upto 7 months after randomization | including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke |
| Secondary | Number of Participants With Overall Cardiovascular Events | upto 7 months after randomization | including nonfatal stroke, nonfatal myocardial infarction and vascular death. |
| Secondary | Number of Patients With Ipsilateral Ischemic Stroke Rate | upto 7 months after randomization | ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis |
| Secondary | Numbers of Fatal or Major Bleeding Complications | upto 7 months after randomization | life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood |
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 | Number of Participants With Progression of Symptomatic Intracranial Stenosis | 7 months after treatment | participants | NUMBER | |
| SECONDARY | Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI | 7 months after treatment | this analysis included the patients who had performed follow-up FLAIR imaging | pariticipants | NUMBER |
| SECONDARY | Number of Participants With Stroke Events | upto 7 months after randomization | this outcome analysis performed on the intention to treat (ITT) method | participants | NUMBER |
| SECONDARY | Number of Participants With Overall Cardiovascular Events | upto 7 months after randomization | this outcome analysis was done intention to treat method | participants | NUMBER |
| SECONDARY | Number of Patients With Ipsilateral Ischemic Stroke Rate | upto 7 months after randomization | this outcome analysis was done ITT method | participants | NUMBER |
| SECONDARY | Numbers of Fatal or Major Bleeding Complications | upto 7 months after randomization | this outcome analysis was done ITT method | events | 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 |
|---|---|---|---|---|---|
| Number of Participants With Progression of Symptomatic Intracranial Stenosis | Cilostazol | 20 | participants | ||
| Number of Participants With Progression of Symptomatic Intracranial Stenosis | Clopidogrel | 32 | participants | ||
| Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI | Cilostazol | 34 | pariticipants | ||
| Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI | Clopidogrel | 23 | pariticipants | ||
| Number of Participants With Stroke Events | Cilostazol | 11 | participants | ||
| Number of Participants With Stroke Events | Clopidogrel | 7 | participants | ||
| Number of Participants With Overall Cardiovascular Events | Cilostazol | 15 | participants | ||
| Number of Participants With Overall Cardiovascular Events | Clopidogrel | 10 | participants | ||
| Number of Patients With Ipsilateral Ischemic Stroke Rate | Cilostazol | 9 | participants | ||
| Number of Patients With Ipsilateral Ischemic Stroke Rate | Clopidogrel | 5 | 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 | 232 | |
| Overall Study | STARTED | Clopidogrel | 225 | |
| Overall Study | COMPLETED | Cilostazol | 202 | |
| Overall Study | COMPLETED | Clopidogrel | 207 | |
| Overall Study | NOT COMPLETED | Cilostazol | 30 | |
| Overall Study | NOT COMPLETED | Clopidogrel | 18 |
Source ClinicalTrials.gov
Adverse events74
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 | headache | Nervous system disorders | Cilostazol | 62 | 232 | 78 |
| other | headache | Nervous system disorders | Clopidogrel | 35 | 225 | 42 |
| other | diarrhea | Gastrointestinal disorders | Cilostazol | 16 | 232 | 18 |
| other | diarrhea | Gastrointestinal disorders | Clopidogrel | 9 | 225 | 10 |
| other | petechia | Blood and lymphatic system disorders | Cilostazol | 0 | 232 | 0 |
| other | petechia | Blood and lymphatic system disorders | Clopidogrel | 3 | 225 | 3 |
| other | dizziness | Nervous system disorders | Cilostazol | 28 | 232 | 29 |
| other | dizziness | Nervous system disorders | Clopidogrel | 21 | 225 | 23 |
| other | palpitation | Cardiac disorders | Cilostazol | 7 | 232 | 7 |
| other | palpitation | Cardiac disorders | Clopidogrel | 3 | 225 | 3 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 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 | Clopidogrel | ||
| Total, other adverse events | Cilostazol | 232 | 232 |
| Total, other adverse events | Clopidogrel | 225 | 225 |
| Total, serious adverse events | Cilostazol | 54 | 232 |
| Total, serious adverse events | Clopidogrel | 54 | 225 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cilostazol vs Clopidogrel: Number of Participants With Overall Cardiovascular Events | Trial comparisons |
| Cilostazol vs Clopidogrel: Number of Participants With Progression of Symptomatic Intracranial Stenosis | Trial comparisons |
| Cilostazol vs Clopidogrel: Number of Patients With Ipsilateral Ischemic Stroke Rate | Trial comparisons |
| Cilostazol vs Clopidogrel: Number of Participants With Stroke Events | Trial comparisons |
| Cilostazol vs Clopidogrel: 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/NCT00130039
GET https://conductscience.org/api/trials/v1/NCT00130039/events?page=2