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The purpose of this study is to investigate the effect of cilostazol loading before planned PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol loading | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the cilostazol group received 200 mg of cilostazol (loading dose) 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) | at 3 months after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Late loss on quantitative coronary angiography | 9 months after index PCI | |
| % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS | 9 months after index PCI | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyeon-Cheol Gwon, MD, PhD | Contact | 82-2-3410-3418 | hc.gwon@samsung.com | |
| Young Bin Song, MD, PhD | Contact | 82-2-3410-1333 | youngbin.song@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyeon-Cheol Gwon, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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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 | Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months. |
|
| Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) |
| 12 months after index PCI |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |