OPERATION trial

JRCT ID: jRCT1051240246

Registered date:22/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronary Artery Disease, Abnominal Disease
• Date of first enrollment: 22/01/2025
• Target sample size: 1200
• Study type: Interventional
• Intervention(s): Aspirin continuation/interruption in the perioperative period of abdominal surgery

Outcome(s)

• Primary Outcome: All-cause death/myocardial infarction

Secondary Outcome

- [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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude 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.

Related Information

• Primary Sponsor: Hiroki Shiomi
• Source(s) of Monetary Support: Japan Agency Medical Research and Development
• Secondary ID(s): NCT06723145