Antiplatelet AgentsPhase 4OPERATIONNCT06723145
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
A Phase 4 study testing Aspirin and Aspirin interruption in people with Antiplatelet Agents and Perioperative Care, run by Kyoto University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Antiplatelet Agents, Perioperative Care
- What is being tested?
- Aspirin and Aspirin interruption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jan 2025to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of coronary stenting and scheduled for abdominal surgery
- Patients on a single antiplatelet agent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
Hiroki Shiomi, MD, +81-75-751-4255, hishiomi@kuhp.kyoto-u.ac.jp
About this study
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.
Read the 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.
- Conditions
- Antiplatelet Agents, Perioperative Care
- Being tested
- Aspirin, Aspirin interruption
- Keywords
- antiplatelet agents, perioperative care, coroanry artery disease, abdominal disease, noncardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Aspirin (drug)
perioperative aspirin continuation
Aspirin interruptionDrug
Also called Aspirin interruption (drug)
Aspirin interruption 5-7 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Continuation | Experimental | perioperative aspirin continuation Receives: Drug: Aspirin |
| Interruption of Antiplatelet Therapy | Active comparator | Interruption of aspirin 5-7 days before surgery Receives: Drug: Aspirin interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (24)
Major bleeding (TIMI major/minor bleeding)
TIMI major/minor bleeding
Measured: 30 days
Death/Myocardial Infarction (4th UDMI Definition)/Stroke
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke
Measured: 30 days
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
Measured: 30 days
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
Measured: 30 days
Death/Myocardial Infarction (ARC-2 Definition)/Stroke
a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke
Measured: 30 days
Death
all-cause death
Measured: 30 days
Cardiovascular Death
cardac and vascular death
Measured: 30 days
Myocardial Infarction (4th UDMI Definition)
Myocardial Infarction defined by 4th UDMI Definition
Measured: 30 days
Myocardial Infarction (ARC-2 Definition)
Myocardial Infarction defined by ARC-2 Definition
Measured: 30 days
Myocardial Infarction (SCAI Definition)
Myocardial Infarction defined by SCAI Definition
Measured: 30 days
Myocardial Infarction (modified POISE-2 Definition)
Myocardial Infarction defined by modified POISE-2 Definition
Measured: 30 days
Myocardial Injury (MINS)
Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes.
Measured: 30 days
Stent Thrombosis (ARC Definition)
Stent thrombosis defined by ARC definition
Measured: 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.
Measured: 30 days
Cerebral Infarction
Sudden neurological disorder that persists for at least 24 hours and is caused by infarction.
Measured: 30 days
Cerebral Hemorrhage
Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding.
Measured: 30 days
Coronary Revascularization
PCI or CABG
Measured: 30 days
Major Bleeding (BARC classification)
Major bleeding defined by BARC classification
Measured: 30 days
Major Bleeding (modified POISE-2 classification)
Major bleeding defined by modified POISE-2 classification
Measured: 30 days
Major Bleeding (GUSTO classification)
Major bleeding defined by GUSTO classification
Measured: 30 days
Fatal Bleeding
Fatal bleeding within 30 days after abdominal surgery
Measured: 30 days
Bleeding Volume During Non-Cardiac Surgery
bleeding volume during abdominal surgery
Measured: 30 days
Transfusion
transfusion during and after surgery
Measured: 30 days
Reoperation
any reoperation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start20 Jan 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroki Shiomi, Kyoto University
- Investigators
- Hiroki Shiomi, MD, PhD, Principal investigator, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723145
- Sponsor's protocol ID
- Y0211
- Other IDs
- 24ek0210198h0001
- Acronym
- OPERATION
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
- ClinicalTrials.gov ID
- NCT06723145
- Acronym / sponsor ID
- OPERATION / Y0211
- Conditions
- Antiplatelet Agents, Perioperative Care
- Keywords
- antiplatelet agents, perioperative care, coroanry artery disease, abdominal disease, noncardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin Continuation | Experimental | Drug: Aspirinperioperative aspirin continuation |
| Interruption of Antiplatelet Therapy | Active comparator | Drug: Aspirin interruptionInterruption of aspirin 5-7 days before surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a history of coronary stenting and scheduled for abdominal surgery
- Patients on a single antiplatelet agent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Aspirin (drug)perioperative aspirin continuation | Drug | Aspirin Continuation |
| Aspirin interruptionAlso: Aspirin interruption (drug)Aspirin interruption 5-7 days before surgery | Drug | Interruption of Antiplatelet Therapy |
Primary outcome
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)
24 secondary outcomes
Major bleeding (TIMI major/minor bleeding)
Time frame: 30 days
Death/Myocardial Infarction (4th UDMI Definition)/Stroke
Time frame: 30 days
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
Time frame: 30 days
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
Time frame: 30 days
Death/Myocardial Infarction (ARC-2 Definition)/Stroke
Time frame: 30 days
Death
Time frame: 30 days
Cardiovascular Death
Time frame: 30 days
Myocardial Infarction (4th UDMI Definition)
Time frame: 30 days
Myocardial Infarction (ARC-2 Definition)
Time frame: 30 days
Myocardial Infarction (SCAI Definition)
Time frame: 30 days
Myocardial Infarction (modified POISE-2 Definition)
Time frame: 30 days
Myocardial Injury (MINS)
Time frame: 30 days
Stent Thrombosis (ARC Definition)
Time frame: 30 days
Stroke
Time frame: 30 days
Cerebral Infarction
Time frame: 30 days
Cerebral Hemorrhage
Time frame: 30 days
Coronary Revascularization
Time frame: 30 days
Major Bleeding (BARC classification)
Time frame: 30 days
Major Bleeding (modified POISE-2 classification)
Time frame: 30 days
Major Bleeding (GUSTO classification)
Time frame: 30 days
Fatal Bleeding
Time frame: 30 days
Bleeding Volume During Non-Cardiac Surgery
Time frame: 30 days
Transfusion
Time frame: 30 days
Reoperation
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hiroki Shiomi, MD, PhD principal investigator
Kyoto University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Aspirin interruption in people with Antiplatelet Agents and Perioperative Care, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hiroki Shiomi, MD, PhD (+81-75-751-4255, hishiomi@kuhp.kyoto-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite of death or myocardial infarction (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.