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| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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RATIONALE:
OBJECTIVES:
TREATMENTS:
TREATMENT PLAN:
PRIMARY ENDPOINT:
STUDY EXECUTION:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asprin (100mg) plus placebo | Placebo Comparator | Asprin (100mg) plus placebo |
|
| Asprin (100mg) plus cilostazol (200mg) | Active Comparator | Asprin (100mg) plus cilostazol (200mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Asprin (100mg) plus placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study | The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling's PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study. | 14 days and 90 days from the baseline TCD study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With First Recurrent Stroke of Any Type | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Hyeon Park, MD, PhD | Sanggye Paik Hospital, Inje University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanbon Medical Center | Gunpo | 435-040 | South Korea | |||
| National Health Insurance Corporation Ilsan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23128968 | Derived | Han SW, Lee SS, Kim SH, Lee JH, Kim GS, Kim OJ, Koh IS, Lee JY, Suk SH, Lee SI, Nam HS, Kim WJ, Yong SW, Lee KY, Park JH. Effect of cilostazol in acute lacunar infarction based on pulsatility index of transcranial Doppler (ECLIPse): a multicenter, randomized, double-blind, placebo-controlled trial. Eur Neurol. 2013;69(1):33-40. doi: 10.1159/000338247. Epub 2012 Nov 1. |
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A total of 513 patients who had experienced their first classic lacunar syndromes were screened for study enrollment, of which 101 (19.7% of the screened population) refused to participate in the study. Seventy-four patients (14.4%) were not eligible for the trial, and 135 (26.3%) were excluded by the exclusion criteria.
ECLIPse was designed as a multicenter, randomized, double-blind, placebo-controlled trial. Between November 2006 and October 2008, 203 patients were consecutively enrolled from eight tertiary-care hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Asprin Plus Placebo | Placebo twice a day on top of aspirin 100mg a day |
| FG001 | Asprin Plus Cilostazol | Cilostazol (100mg) twice a day on top of aspirin 100mg a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asprin Plus Placebo | Placebo twice a day on top of aspirin 100mg a day |
| BG001 | Asprin Plus Cilostazol | Cilostazol (100mg) twice a day on top of aspirin 100mg a day |
| 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 | The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study | The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling's PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study. | Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome. | Posted | Mean | Standard Deviation | ratio | 14 days and 90 days from the baseline TCD study |
|
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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 | Asprin Plus Placebo | Placebo twice a day on top of aspirin 100mg a day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sang Won Han | Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine | 82-2-950-8864 | swhan@paik.ac.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 |
|---|---|
| D001241 | Aspirin |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| cilostazol |
| Drug |
Aspirin (100mg) plus cilostazol (200mg) |
|
|
| Ilsan |
| 411-719 |
| South Korea |
| Bundang CHA Hospital | Seongnam | 463-712 | South Korea |
| National medical center | Seoul | 100-799 | South Korea |
| Yongdong Severance Hospital | Seoul | 135-720 | South Korea |
| Sanggye Paik Hospital | Seoul | 139-707 | South Korea |
| Ajou University Hospital | Suwon | 443-721 | South Korea |
| Wonju Christian Hospital | Wŏnju | 220-701 | South Korea |
| Protocol Violation |
|
| Primary Outcome |
|
| 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 |
|
| OG001 | Asprin Plus Cilostazol | Cilostazol (100mg) twice a day on top of aspirin 100mg a day |
|
|
|
| Secondary | Number of Patients With First Recurrent Stroke of Any Type | Posted | Number | participants | 90 days |
|
|
|
|
| 0 |
| 83 |
| 0 |
| 103 |
| EG001 | Asprin Plus Cilostazol | Cilostazol (100mg) twice a day on top of aspirin 100mg a day | 0 | 81 | 0 | 100 |
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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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |