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| ID | Type | Description | Link |
|---|---|---|---|
| 24ek0210198h0001 | Other Grant/Funding Number | Japan Agency for Medical Research and Development |
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The purpose of this study is to evaluate the impact of perioperative aspirin continuation on clinical outcomes in patients with a history of coronary stent implantation who are scheduled for abdominal surgery.
PCI with coronary stent implantation is performed for a huge number of patients with coronary artery disease. Approximately 20% of these patients undergo non-cardiac surgery within three years after PCI. However, there is a scarcity of clinical evidence regarding the efficacy of perioperative aspirin continuation on cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin Continuation | Experimental | perioperative aspirin continuation |
|
| Interruption of Antiplatelet Therapy | Active Comparator | Interruption of aspirin 5-7 days before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | perioperative aspirin continuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| a composite of death or myocardial infarction | the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding (TIMI major/minor bleeding) | TIMI major/minor bleeding | 30 days |
| Death/Myocardial Infarction (4th UDMI Definition)/Stroke | a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroki Shiomi, MD, PhD | Contact | +81-75-751-4255 | hishiomi@kuhp.kyoto-u.ac.jp | |
| Erika Yamamoto, MD, PhD | Contact | +81-75-751-4254 | erkymmt@kuhp.kyoto-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiroki Shiomi, MD, PhD | Kyoto University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Recruiting | Kyoto | 606-8507 | Japan |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin interruption | Drug | Aspirin interruption 5-7 days before surgery |
|
|
| 30 days |
| Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS) | a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS) | 30 days |
| Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS) | a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS) | 30 days |
| Death/Myocardial Infarction (ARC-2 Definition)/Stroke | a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke | 30 days |
| Death | all-cause death | 30 days |
| Cardiovascular Death | cardac and vascular death | 30 days |
| Myocardial Infarction (4th UDMI Definition) | Myocardial Infarction defined by 4th UDMI Definition | 30 days |
| Myocardial Infarction (ARC-2 Definition) | Myocardial Infarction defined by ARC-2 Definition | 30 days |
| Myocardial Infarction (SCAI Definition) | Myocardial Infarction defined by SCAI Definition | 30 days |
| Myocardial Infarction (modified POISE-2 Definition) | Myocardial Infarction defined by modified POISE-2 Definition | 30 days |
| Myocardial Injury (MINS) | Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes. | 30 days |
| Stent Thrombosis (ARC Definition) | Stent thrombosis defined by ARC definition | 30 days |
| Stroke | Sudden neurological disorder that persists for at least 24 hours and is caused by blockage of cerebral blood flow due to bleeding or ischemia. | 30 days |
| Cerebral Infarction | Sudden neurological disorder that persists for at least 24 hours and is caused by infarction. | 30 days |
| Cerebral Hemorrhage | Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding. | 30 days |
| Coronary Revascularization | PCI or CABG | 30 days |
| Major Bleeding (BARC classification) | Major bleeding defined by BARC classification | 30 days |
| Major Bleeding (modified POISE-2 classification) | Major bleeding defined by modified POISE-2 classification | 30 days |
| Major Bleeding (GUSTO classification) | Major bleeding defined by GUSTO classification | 30 days |
| Fatal Bleeding | Fatal bleeding within 30 days after abdominal surgery | 30 days |
| Bleeding Volume During Non-Cardiac Surgery | bleeding volume during abdominal surgery | 30 days |
| Transfusion | transfusion during and after surgery | 30 days |
| Reoperation | any reoperation | 30 days |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |