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| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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This study will recruit 316 ischemic stroke patients taking aspirin.
They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.
The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.
[Goal] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.
[Trial Design] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
[Participants] Ischemic stroke patients taking aspirin
[Methods]
[Outcome Variables]
Primary Outcome Variable:
• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA
Secondary outcome variables:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Cilostazol | Experimental | 100mg of Cilostazol twice a day |
|
| Placebo | Placebo Comparator | matching placebo to cilostazol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | cilostazol 100mg twice a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aspirin Resistance (ARU ≥ 550) | The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients | 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Aspirin Resistance (ARU ≥ 500) | The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values | 4 weeks after reatment |
| Bleeding Time (BT) | for evaluation of the extent of the bleeding time prolongation by additional cilostazol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun U Kwon, MD. PhD. | Asan Medical Center, Univsersity of Ulsan, Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jae-Kwan Cha | Busan | Busan | 602-715 | South Korea | ||
| Eulji University Hospital |
Patients with aspirin therapy were recruited due to subacute or chronic ischemic stroke.
The patients should have taken aspirin 100mg per day at least 2 weeks before randomization
244 patients with subacute or chronic ischemic stroke were recruited from outpatient clinics of 5 comprehensive stroke centers of Korea
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilostazol | Cilostazol 100mg twice per day |
| FG001 | Placebo | matching placebo to cilostazol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilostazol | Cilostazol 100mg twice per day |
| BG001 | Placebo | matching placebo to cilostazol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aspirin Resistance (ARU ≥ 550) | The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients | Posted | Number | participants | 4 weeks after treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilostazol | Cilostazol 100mg twice per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Sun U. Kwon | Asan Medical Center, University of Ulsan College of Medicine | 82-2-3010-3960 | sukwon@amc.seoul.kr |
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| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | placebo 1 tablet twice a day matching for cilostazol |
|
|
| 4 weeks after reatment |
| Fatal or Major Bleeding Complications; | Fatal or life-threatening 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 | events ocurred during study medication after randomization |
| Any Bleeding Complications | any bleeding events causing medical attention | events ocurred during study medication after randomization |
| Difference of Post-treatment ARU and Baseline ARU | summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients | baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication |
| Post-treatment ARU | mean of ARU value of individual participants after 4 weeks treatment | after 4 weeks treatment |
| Daejeon |
| 302-799 |
| South Korea |
| Kangdong Sacred Heart Hospital, Hallym University | Seoul | 134-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Lost to Follow-up |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Aspirin Resistance (ARU ≥ 500) | The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values | Posted | Number | participants | 4 weeks after reatment |
|
|
|
| Secondary | Bleeding Time (BT) | for evaluation of the extent of the bleeding time prolongation by additional cilostazol | Posted | Mean | Standard Deviation | seconds | 4 weeks after reatment |
|
|
|
| Secondary | Fatal or Major Bleeding Complications; | Fatal or life-threatening 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 | Posted | Number | participants | events ocurred during study medication after randomization |
|
|
|
| Secondary | Any Bleeding Complications | any bleeding events causing medical attention | Posted | Number | participants | events ocurred during study medication after randomization |
|
|
|
| Secondary | Difference of Post-treatment ARU and Baseline ARU | summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients | Posted | Mean | Standard Deviation | change of ARU measured | baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication |
|
|
|
| Secondary | Post-treatment ARU | mean of ARU value of individual participants after 4 weeks treatment | Posted | Mean | Standard Deviation | ARU | after 4 weeks treatment |
|
|
|
| 0 |
| 125 |
| 7 |
| 125 |
| EG001 | Placebo | matching placebo to cilostazol | 0 | 119 | 2 | 119 |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |