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Objectives :
Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol
Patient Enrollment: 960 patients enrolled at 5 centers in Korea
Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure.
Primary Endpoint
Secondary Endpoint
Safety Endpoint
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAT | Active Comparator | triple antiplatelet therapy : aspirin, clopidogrel and cilostazol |
|
| DAT | Placebo Comparator | dual antiplatelet therapy : aspirin, clopidogrel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cilostazol | Drug | Pletaal (Otsuka Pharm.) 100mg bid for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of adverse cardiovascular outcomes | composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization | six months |
| Measure | Description | Time Frame |
|---|---|---|
| all cause of death | six months | |
| stent thrombosis | six months | |
| each component of primary endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, MD,PhD | Seoul National University Hospital | Principal Investigator |
| In-Ho Chae, MD, PhD | Seoul National University Bundang Hospital | Study Chair |
| Jang-Ho Bae, MD, PhD | Gonyang University Hospital | Study Chair |
| Myung-Chan Cho, MD, PhD | Chungbuk National University Hospital | Study Chair |
| Seung-Woon Rha, MD, PhD | Korea University Guro Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224730 | Derived | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. | |
| 21232664 | Derived | Suh JW, Lee SP, Park KW, Lee HY, Kang HJ, Koo BK, Cho YS, Youn TJ, Chae IH, Choi DJ, Rha SW, Bae JH, Kwon TG, Bae JW, Cho MC, Kim HS. Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. J Am Coll Cardiol. 2011 Jan 18;57(3):280-9. doi: 10.1016/j.jacc.2010.08.631. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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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| six months |
| PRU level | at discharge after the index procedure |
| PRU level | six months after the index procedure |
| 20735821 | Derived | Lee SP, Suh JW, Park KW, Lee HY, Kang HJ, Koo BK, Chae IH, Choi DJ, Rha SW, Bae JW, Cho MC, Kwon TG, Bae JH, Kim HS; CILON-T investigators. Study design and rationale of 'Influence of Cilostazol-based triple anti-platelet therapy on ischemic complication after drug-eluting stent implantation (CILON-T)' study: A multicenter randomized trial evaluating the efficacy of Cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease. Trials. 2010 Aug 24;11:87. doi: 10.1186/1745-6215-11-87. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |