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

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.

Study Overview

• Status: Recruiting
• Conditions: Perioperative Care; Antiplatelet Agents
• Intervention / Treatment: Drug: Aspirin; Drug: Aspirin interruption

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 Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hiroki Shiomi, MD, PhD; Phone Number: +81-75-751-4255; Email: hishiomi@kuhp.kyoto-u.ac.jp
• Study Contact Backup: Name: Erika Yamamoto, MD, PhD; Phone Number: +81-75-751-4254; Email: erkymmt@kuhp.kyoto-u.ac.jp

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Recruiting
    • Kyoto University Hospital
    • Contact: Hiroki Shiomi, MD; Phone Number: +81-75-751-4255; Email: hishiomi@kuhp.kyoto-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspirin Continuation; perioperative aspirin continuation	Drug: Aspirin; perioperative aspirin continuation; Other Names: Aspirin (drug)
Active Comparator: Interruption of Antiplatelet Therapy; Interruption of aspirin 5-7 days before surgery	Drug: Aspirin interruption; Aspirin interruption 5-7 days before surgery; Other Names: Aspirin interruption (drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kyoto University
• Investigators: Principal Investigator: Hiroki Shiomi, MD, PhD, Kyoto University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: noncardiac surgery; perioperative care; antiplatelet agents; coroanry artery disease; abdominal disease
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin
• Other Study ID Numbers: Y0211; 24ek0210198h0001 (Other Grant/Funding Number: Japan Agency for Medical Research and Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No