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

February 9, 2025 updated by: Hiroki Shiomi, Kyoto University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
a composite of death or myocardial infarction
Time Frame: 30 days
the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major bleeding (TIMI major/minor bleeding)
Time Frame: 30 days
TIMI major/minor bleeding
30 days
Death/Myocardial Infarction (4th UDMI Definition)/Stroke
Time Frame: 30 days
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke
30 days
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
Time Frame: 30 days
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
30 days
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
Time Frame: 30 days
a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
30 days
Death/Myocardial Infarction (ARC-2 Definition)/Stroke
Time Frame: 30 days
a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke
30 days
Death
Time Frame: 30 days
all-cause death
30 days
Cardiovascular Death
Time Frame: 30 days
cardac and vascular death
30 days
Myocardial Infarction (4th UDMI Definition)
Time Frame: 30 days
Myocardial Infarction defined by 4th UDMI Definition
30 days
Myocardial Infarction (ARC-2 Definition)
Time Frame: 30 days
Myocardial Infarction defined by ARC-2 Definition
30 days
Myocardial Infarction (SCAI Definition)
Time Frame: 30 days
Myocardial Infarction defined by SCAI Definition
30 days
Myocardial Infarction (modified POISE-2 Definition)
Time Frame: 30 days
Myocardial Infarction defined by modified POISE-2 Definition
30 days
Myocardial Injury (MINS)
Time Frame: 30 days
Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes.
30 days
Stent Thrombosis (ARC Definition)
Time Frame: 30 days
Stent thrombosis defined by ARC definition
30 days
Stroke
Time Frame: 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.
30 days
Cerebral Infarction
Time Frame: 30 days
Sudden neurological disorder that persists for at least 24 hours and is caused by infarction.
30 days
Cerebral Hemorrhage
Time Frame: 30 days
Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding.
30 days
Coronary Revascularization
Time Frame: 30 days
PCI or CABG
30 days
Major Bleeding (BARC classification)
Time Frame: 30 days
Major bleeding defined by BARC classification
30 days
Major Bleeding (modified POISE-2 classification)
Time Frame: 30 days
Major bleeding defined by modified POISE-2 classification
30 days
Major Bleeding (GUSTO classification)
Time Frame: 30 days
Major bleeding defined by GUSTO classification
30 days
Fatal Bleeding
Time Frame: 30 days
Fatal bleeding within 30 days after abdominal surgery
30 days
Bleeding Volume During Non-Cardiac Surgery
Time Frame: 30 days
bleeding volume during abdominal surgery
30 days
Transfusion
Time Frame: 30 days
transfusion during and after surgery
30 days
Reoperation
Time Frame: 30 days
any reoperation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyoto University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hiroki Shiomi, MD, PhD, Kyoto University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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