Clinical trial NCT06723145: Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
Official title: Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Antiplatelet Agents
Perioperative Care
Keywords: antiplatelet agents
perioperative care
coroanry artery disease
abdominal disease
noncardiac surgery
Lead sponsor: Kyoto University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a history of coronary stenting and scheduled for abdominal surgery
* Patients on a single antiplatelet agent

Exclusion Criteria:

* Patients on dual antiplatelet therapy (DAPT)
* Patients on anticoagulation therapy
* Patients with a history of stent thrombosis
* Patients with CHADS2 score \>= 5
* Patients at extremely high risk of bleeding and unable to continue preoperative aspirin
* Patients incapable of consent, including those under 20 years of age
* Other patients for whom either discontinuation or continuation of antiplatelet agents is deemed inappropriate by the attending physician

Primary outcomes:
measure: a composite of death or myocardial infarction
timeFrame: 30 days
Secondary outcomes:
measure: Major bleeding (TIMI major/minor bleeding)
timeFrame: 30 days
measure: Death/Myocardial Infarction (4th UDMI Definition)/Stroke
timeFrame: 30 days
measure: Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
timeFrame: 30 days
measure: Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
timeFrame: 30 days
measure: Death/Myocardial Infarction (ARC-2 Definition)/Stroke
timeFrame: 30 days
measure: Death
timeFrame: 30 days
measure: Cardiovascular Death
timeFrame: 30 days
measure: Myocardial Infarction (4th UDMI Definition)
timeFrame: 30 days
measure: Myocardial Infarction (ARC-2 Definition)
timeFrame: 30 days
measure: Myocardial Infarction (SCAI Definition)
timeFrame: 30 days
measure: Myocardial Infarction (modified POISE-2 Definition)
timeFrame: 30 days
measure: Myocardial Injury (MINS)
timeFrame: 30 days
measure: Stent Thrombosis (ARC Definition)
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Cerebral Infarction
timeFrame: 30 days
measure: Cerebral Hemorrhage
timeFrame: 30 days
measure: Coronary Revascularization
timeFrame: 30 days
measure: Major Bleeding (BARC classification)
timeFrame: 30 days
measure: Major Bleeding (modified POISE-2 classification)
timeFrame: 30 days
measure: Major Bleeding (GUSTO classification)
timeFrame: 30 days
measure: Fatal Bleeding
timeFrame: 30 days
measure: Bleeding Volume During Non-Cardiac Surgery
timeFrame: 30 days
measure: Transfusion
timeFrame: 30 days
measure: Reoperation
timeFrame: 30 days
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Hiroki Shiomi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: