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Investigator judged that this study can not be maintained because participant registration rate is low.
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Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).
Most current guidelines recommend to focus on continuing antiplatelet therapy (mostly with aspirin) during noncardiac surgery if possible. Although previous study showed efficacy of continuous antiplatelet therapy in reducing perioperative ischemic cardiovascular events, its effectiveness is still not clear between perioperative bleeding and ischemic risk. Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuing aspirin | Active Comparator | Patients in the group may continue the administration of aspirin during perioperative period. |
|
| Stopping aspirin | Experimental | Patients in the group may stop medication of antiplatelet drugs during perioperative period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuing aspirin | Drug | Subject assigned to control arm will maintain antiplatelet therapy using aspirin only at least 7 days before surgery. If subject is taking one or more antiplatelet drugs, it should be changed (for subjects taking antiplatelet drug except aspirin at enrollment) or continued (for subject taking aspirin at enrollment) with low-dose, aspirin monotherapy before surgery. Cessation of clopidogrel, ticagrelor, and prasugrel should be started at least 5 days, 3 days and 7 days before surgery, respectively. Administration of aspirin will be started at the day of cessation of previous antiplatelet regimen and maintained until third postoperative day with 100 mg once a day. |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of cardiac death | A composite of major perioperative adverse events | 1 day after discharging from the hospital |
| nonfatal myocardial infarction (MI) | A composite of major perioperative adverse events | 1 day after discharging from the hospital |
| cerebrovascular accident | A composite of major perioperative adverse events | 1 day after discharging from the hospital |
| definite or probable stent thrombosis | A composite of major perioperative adverse events | 1 day after discharging from the hospital |
| any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure | A composite of major perioperative adverse events | 1 day after discharging from the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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| Stopping aspirin | Drug | Subject assigned to comparison arm will stop antiplatelet therapy before scheduled surgery or procedure. If subject is taking aspirin, clopidogrel, ticagrelor, or prasugrel, it should be discontinued for 7 days, 5 days, 3-5 days, and 7 days before surgery. Antiplatelet therapy may be restarted as previous regimen at fourth postoperative day or sooner unless significant bleeding risk or bleeding event occurs. |
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| 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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