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This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin with clopidogrel | Active Comparator | aspirin 100mg with clopidogrel 75mg for 21 days |
|
| aspirin with cilostazol | Experimental | aspirin 100mg with cilostazol 200 mg for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | patients were given cilostazol 100mg twice a day with aspirin |
|
| Measure | Description | Time Frame |
|---|---|---|
| New stroke event for 90 days (Ischemic or hemorrhagic) | New stroke event for 90 days (Ischemic or hemorrhagic) | for 90 days |
| Moderate-to-severe bleeding event according to (GUSTO) definition | Moderate-to-severe bleeding event according to (GUSTO) definition: Moderate : bleeding requiring transfusion Severe : Fatal or intracerebral bleeding, or bleeding resulting in substantial hemodynamic compromise requiring treatment | for 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. | New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taewon Kim, Dr | the catholic university of korea, neurology department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic university of korea, Incheon St. Mary's hospital | Incheon | South Korea |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clopidogrel | Drug | patients were given clopidogrel 75mg with aspirin |
|
|
| for 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |