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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.
Subjects who can not be randomized due to any reason will be enrolled at observational group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin only | Experimental |
| |
| No antiplatelet therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin only | Drug | Aspirin only during surgery |
| |
| No antiplatelet therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of all cause death | 30 days | |
| The event rate of cardiac death | 30 days | |
| The event rate of myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaslok Hospital | Mumbai | India | ||||
| Asan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39217573 | Derived | Kang DY, Lee SH, Lee SW, Lee CH, Kim C, Jang JY, Mehta N, Oh JH, Cho YR, Yoon KH, Ahn SG, Lee JH, Cho DK, Kim Y, Kim J, Cho GH, Lee KS, Park H, Vural M, Lim YH, Park KH, Lee BK, Lee JY, Park HW, Yoon YH, Lee JH, Lee SY, Park KW, Kang J, Kim HK, Kang SH, Park JH, Choi IC, Yu CS, Yun SC, Park DW, Hong MK, Park SJ, Kim JS, Ahn JM; ASSURE DES Investigators. Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery. J Am Coll Cardiol. 2024 Dec 10;84(24):2380-2389. doi: 10.1016/j.jacc.2024.08.024. Epub 2024 Aug 31. |
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| Drug |
No antiplatelet therapy will be during surgery |
|
| 30 days |
| The event rate of stroke | 30 days |
| The event rate of stent thrombosis | 30 days |
| The event rate of repeat revascularization | 30 days |
| The event rate of life threatening bleeding | 30 days |
| The event rate of major bleeding | 30 days |
| Quality of life score assessed by the EQ-5D-5L | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively. | 30 days |
| Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8) | HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness. Higher score of HINT-8 means the high quality of life. The minimum and maximum values are 0 and 100 respectively if convert to a percentage. | 30 days |
| Cost-effective analysis | Cost-effective analysis based on average treatment costs for two perioperative antiplatelet therapy_Aspirin only vs. No antiplatelet therapy_in patients with drug-eluting stent undergoing non-cardiac surgery. | 30 days |
| Seoul |
| Songpa-gu |
| 138-736 |
| South Korea |
| Hallym University Sacred Heart Hospital | Anyang | South Korea |
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | South Korea |
| Dong-A Medical Center | Busan | South Korea |
| Pusan National University Yangsan Hospital | Busan | South Korea |
| Soon Chun Hyang University Hospital Cheonan | Cheonan | South Korea |
| Chungbuk National University Hospital | Cheonju | South Korea |
| Gangwon National Univ. Hospital | Chuncheon | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| The Catholic University of Korea, Daejeon St. Mary's Hosptial | Daejeon | South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Wonkwang University Sanbon Hospital | Gunpo | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Chosun University Hospital | Gwangju | South Korea |
| Wonkwang University Hospital | Iksan | South Korea |
| National Health Insurance Service Ilsan Hospital | Ilsan | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Sejong Chungnam National University Hospital | Sejong | South Korea |
| Ewha Womans University Medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Hanyang University Seoul Hospital | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| Yongin Severance Hospital | Yŏngin | South Korea |
| Bagcilar Education and Training Hospital | Istanbul | Turkey (Türkiye) |
| SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital | Istanbul | Turkey (Türkiye) |