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Slow enrollment
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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
| Medtronic | INDUSTRY |
| Chong Kun Dang Pharmaceutical Corp. | INDUSTRY |
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The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short term dual therapy | Experimental |
| |
| Long term dual therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | 6-month DAPT followed by clopidogrel monotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically relevant bleeding | clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with death from cardiovascular cause | 18 months | |
| Number of participants with myocardial infarction | 18 months | |
| Number of participants with stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD | Asan Medical Center | Principal Investigator |
| Cheol-Whan Lee, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | South Korea | ||||
| Eulji University Hospital |
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| Aspirin plus clopidogrel |
| Drug |
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) |
|
| 18 months |
| Number of participants with stent thrombosis | 18 months |
| Number of participants with repeat revascularization | 18 months |
| Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5 | 18 months |
| Number of participants with a composite of death from vascular causes or myocardial infarction | 18 months |
| Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis | 18 months |
| Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5 | 18 months |
| Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding) | 18 months |
| Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects. | 18 months |
| Daejeon |
| South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Inje University Ilsan Paik Hospital | Ilsan | South Korea |
| Cheju Halla General Hospital | Jeju City | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Kangbuk Samsung Medical Center | Seoul | South Korea |
| Kyunghee University Medical Center | Seoul | South Korea |
| SMA-SNU Boramae Medical Center | Seoul | South Korea |
| The Catholic University of Korea St. Paul's Hospital | Seoul | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
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