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

Kyoto University

Status and phase: Enrolling; Phase 4

Conditions: Antiplatelet Agents; Perioperative Care

Treatments: Drug: Aspirin interruption; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT06723145

Y0211

24ek0210198h0001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Aspirin Continuation

Experimental group

Description:

perioperative aspirin continuation

Treatment:

Drug: Aspirin

Interruption of Antiplatelet Therapy

Active Comparator group

Description:

Interruption of aspirin 5-7 days before surgery

Treatment:

Drug: Aspirin interruption