CClinicalTrials.gg
RecruitingNCT06723145OPERATIONUpdated Feb 11, 2025

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

A Phase 4 interventional study of Aspirin and Aspirin interruption in Antiplatelet Agents and Perioperative Care, sponsored by Kyoto University. Recruiting at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Kyoto University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Antiplatelet Agents
  • Perioperative Care

Keywords

  • antiplatelet agents
  • perioperative care
  • coroanry artery disease
  • abdominal disease
  • noncardiac surgery
03

In context

Lead sponsor

Kyoto University is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Aspirin Continuation

    perioperative aspirin continuation

    Drug: Aspirin

  • Active comparator
    Interruption of Antiplatelet Therapy

    Interruption of aspirin 5-7 days before surgery

    Drug: Aspirin interruption

Interventions

  • DrugAspirin

    perioperative aspirin continuation

    Also known as: Aspirin (drug)

  • DrugAspirin interruption

    Aspirin interruption 5-7 days before surgery

    Also known as: Aspirin interruption (drug)

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 30 days

Secondary outcomes

  1. Major bleeding (TIMI major/minor bleeding)

    TIMI major/minor bleeding

    Time frame: 30 days

  2. Death/Myocardial Infarction (4th UDMI Definition)/Stroke

    a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke

    Time frame: 30 days

  3. Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)

    a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)

    Time frame: 30 days

  4. Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)

    a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)

    Time frame: 30 days

  5. Death/Myocardial Infarction (ARC-2 Definition)/Stroke

    a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke

    Time frame: 30 days

  6. Death

    all-cause death

    Time frame: 30 days

  7. Cardiovascular Death

    cardac and vascular death

    Time frame: 30 days

  8. Myocardial Infarction (4th UDMI Definition)

    Myocardial Infarction defined by 4th UDMI Definition

    Time frame: 30 days

  9. Myocardial Infarction (ARC-2 Definition)

    Myocardial Infarction defined by ARC-2 Definition

    Time frame: 30 days

  10. Myocardial Infarction (SCAI Definition)

    Myocardial Infarction defined by SCAI Definition

    Time frame: 30 days

  11. Myocardial Infarction (modified POISE-2 Definition)

    Myocardial Infarction defined by modified POISE-2 Definition

    Time frame: 30 days

  12. Myocardial Injury (MINS)

    Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes.

    Time frame: 30 days

  13. Stent Thrombosis (ARC Definition)

    Stent thrombosis defined by ARC definition

    Time frame: 30 days

  14. 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.

    Time frame: 30 days

  15. Cerebral Infarction

    Sudden neurological disorder that persists for at least 24 hours and is caused by infarction.

    Time frame: 30 days

  16. Cerebral Hemorrhage

    Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding.

    Time frame: 30 days

  17. Coronary Revascularization

    PCI or CABG

    Time frame: 30 days

  18. Major Bleeding (BARC classification)

    Major bleeding defined by BARC classification

    Time frame: 30 days

  19. Major Bleeding (modified POISE-2 classification)

    Major bleeding defined by modified POISE-2 classification

    Time frame: 30 days

  20. Major Bleeding (GUSTO classification)

    Major bleeding defined by GUSTO classification

    Time frame: 30 days

  21. Fatal Bleeding

    Fatal bleeding within 30 days after abdominal surgery

    Time frame: 30 days

  22. Bleeding Volume During Non-Cardiac Surgery

    bleeding volume during abdominal surgery

    Time frame: 30 days

  23. Transfusion

    transfusion during and after surgery

    Time frame: 30 days

  24. Reoperation

    any reoperation

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Kyoto University Hospital
    Kyoto, 606-8507, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06723145
Lead sponsor
Kyoto University
Responsible party
Hiroki Shiomi (Hiroki Shiomi MD, PhD, Kyoto University) — Principal investigator
First posted
Dec 9, 2024
Start date
Jan 20, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Feb 11, 2025

Study contacts

Hiroki Shiomi, MD, PhD
Contact
hishiomi@kuhp.kyoto-u.ac.jp
+81-75-751-4255
Erika Yamamoto, MD, PhD
Contact
erkymmt@kuhp.kyoto-u.ac.jp
+81-75-751-4254
Hiroki Shiomi, MD, PhD
principal investigator · Kyoto University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion