Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation

Phase 4

Recruiting

• Conditions: Antiplatelet Agents; Perioperative Care
• Interventions: Drug: Aspirin; Drug: Aspirin interruption

• Registration Number: NCT06723145
• Lead Sponsor: Kyoto University

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.

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Study Start: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-02-28
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin Continuation	Aspirin	perioperative aspirin continuation
Interruption of Antiplatelet Therapy	Aspirin interruption	Interruption of aspirin 5-7 days before surgery

Primary Outcome Measures

Name	Time	Method
a composite of death or myocardial infarction	30 days	the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)

Secondary Outcome Measures

Name	Time	Method
Myocardial Infarction (modified POISE-2 Definition)	30 days	Myocardial Infarction defined by modified POISE-2 Definition
Myocardial Injury (MINS)	30 days	Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes.
Stent Thrombosis (ARC Definition)	30 days	Stent thrombosis defined by ARC definition
Myocardial Infarction (4th UDMI Definition)	30 days	Myocardial Infarction defined by 4th UDMI Definition
Myocardial Infarction (ARC-2 Definition)	30 days	Myocardial Infarction defined by ARC-2 Definition
Myocardial Infarction (SCAI Definition)	30 days	Myocardial Infarction defined by SCAI Definition
Death/Myocardial Infarction (ARC-2 Definition)/Stroke	30 days	a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke
Death	30 days	all-cause death
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)	30 days	a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)	30 days	a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
Cardiovascular Death	30 days	cardac and vascular death
Major bleeding (TIMI major/minor bleeding)	30 days	TIMI major/minor bleeding
Death/Myocardial Infarction (4th UDMI Definition)/Stroke	30 days	a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke
Stroke	30 days	Sudden neurological disorder that persists for at least 24 hours and is caused by blockage of cerebral blood flow due to bleeding or ischemia.
Cerebral Infarction	30 days	Sudden neurological disorder that persists for at least 24 hours and is caused by infarction.
Cerebral Hemorrhage	30 days	Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding.
Coronary Revascularization	30 days	PCI or CABG
Major Bleeding (BARC classification)	30 days	Major bleeding defined by BARC classification
Major Bleeding (modified POISE-2 classification)	30 days	Major bleeding defined by modified POISE-2 classification
Major Bleeding (GUSTO classification)	30 days	Major bleeding defined by GUSTO classification
Fatal Bleeding	30 days	Fatal bleeding within 30 days after abdominal surgery
Bleeding Volume During Non-Cardiac Surgery	30 days	bleeding volume during abdominal surgery
Transfusion	30 days	transfusion during and after surgery
Reoperation	30 days	any reoperation

Trial Locations

Locations (1)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan