Evaluating aspirin use during abdominal surgery for patients with coronary stents
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
This study tests if continuing aspirin during abdominal surgery helps patients with coronary stents have better outcomes and fewer heart problems compared to those who stop taking it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Kyoto University Academic / other |
| Locations | 1 site (Kyoto) |
| Trial ID | NCT06723145 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of continuing aspirin therapy during abdominal surgery in patients who have undergone coronary stent implantation. It aims to determine whether maintaining aspirin can improve clinical outcomes and reduce cardiovascular events in this population. The study will compare outcomes between patients who continue aspirin and those who temporarily interrupt it. By focusing on patients with a history of coronary artery disease, the research seeks to fill a gap in existing clinical evidence regarding perioperative care.
Who should consider this trial
Good fit: Ideal candidates are patients with a history of coronary stenting who are scheduled for abdominal surgery and are on a single antiplatelet agent.
Not a fit: Patients on dual antiplatelet therapy, anticoagulation therapy, or those at extremely high risk of bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients undergoing abdominal surgery after coronary stent implantation.
How similar studies have performed: While there is limited evidence specifically addressing this approach, similar studies on antiplatelet therapy in surgical settings have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kyoto
- Kyoto University Hospital — Kyoto, Japan (Recruiting)
Study contacts
- Principal investigator: Hiroki Shiomi, MD, PhD — Kyoto University Hospital
- Study coordinator: Hiroki Shiomi, MD, PhD
- Email: hishiomi@kuhp.kyoto-u.ac.jp
- Phone: +81-75-751-4255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.