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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
perioperative aspirin continuation
Aspirin interruption 5-7 days before surgery
Kyoto University Hospital
Kyoto, Japan
RECRUITINGa composite of death or myocardial infarction
the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)
Time frame: 30 days
Major bleeding (TIMI major/minor bleeding)
TIMI major/minor bleeding
Time frame: 30 days
Death/Myocardial Infarction (4th UDMI Definition)/Stroke
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke
Time frame: 30 days
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
Time frame: 30 days
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
Time frame: 30 days
Death/Myocardial Infarction (ARC-2 Definition)/Stroke
a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke
Time frame: 30 days
Death
all-cause death
Time frame: 30 days
Cardiovascular Death
cardac and vascular death
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Myocardial Infarction (4th UDMI Definition)
Myocardial Infarction defined by 4th UDMI Definition
Time frame: 30 days
Myocardial Infarction (ARC-2 Definition)
Myocardial Infarction defined by ARC-2 Definition
Time frame: 30 days
Myocardial Infarction (SCAI Definition)
Myocardial Infarction defined by SCAI Definition
Time frame: 30 days
Myocardial Infarction (modified POISE-2 Definition)
Myocardial Infarction defined by modified POISE-2 Definition
Time frame: 30 days
Myocardial Injury (MINS)
Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes.
Time frame: 30 days
Stent Thrombosis (ARC Definition)
Stent thrombosis defined by ARC definition
Time frame: 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.
Time frame: 30 days
Cerebral Infarction
Sudden neurological disorder that persists for at least 24 hours and is caused by infarction.
Time frame: 30 days
Cerebral Hemorrhage
Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding.
Time frame: 30 days
Coronary Revascularization
PCI or CABG
Time frame: 30 days
Major Bleeding (BARC classification)
Major bleeding defined by BARC classification
Time frame: 30 days
Major Bleeding (modified POISE-2 classification)
Major bleeding defined by modified POISE-2 classification
Time frame: 30 days
Major Bleeding (GUSTO classification)
Major bleeding defined by GUSTO classification
Time frame: 30 days
Fatal Bleeding
Fatal bleeding within 30 days after abdominal surgery
Time frame: 30 days
Bleeding Volume During Non-Cardiac Surgery
bleeding volume during abdominal surgery
Time frame: 30 days
Transfusion
transfusion during and after surgery
Time frame: 30 days
Reoperation
any reoperation
Time frame: 30 days