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OPERATION trial

Optimal PERioperative Antiplatelet Therapy Investigation ON abdominal surgery after coronary stent implantation trial - OPERATION

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051240246
Enrollment
1200
Registered
2025-01-22
Start date
2025-02-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Abnominal Disease

Interventions

Aspirin continuation/interruption in the perioperative period of abdominal surgery

Sponsors

Hiroki Shiomi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 inappropriate due to high risk, as determined by the treating physician.

Design outcomes

Primary

MeasureTime frame
All-cause death/myocardial infarction

Secondary

MeasureTime frame
- [Safety endpoints] major bleedings (TIMI major/minor bleeding) - Death/myocardial infarction (4thUDMI definition)/stroke - Death/myocardial infarction (4thUDMI definition)/myocardial impairment (MINS) - Death/Myocardial infarction (ARC-2 definition)/Stroke - Death - Cardiovascular death - Myocardial infarction (4thUDMI definition) - Myocardial infarction (SCAI definition) - Myocardial injury (MINS) - Stent thrombosis (ARC definition) - Stroke - Cerebral infarction - Cerebral hemorrhage - Coronary revascularization - Major bleeding - Fatal bleeding - Bleeding during non-cardiac surgery - Blood transfusion - Reoperation

Contacts

Public ContactShiomi Hiroki

Kyoto University Hospital

hishiomi@kuhp.kyoto-u.ac.jp+81-757514255

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026