Actively Recruiting
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
Led by Kyoto University · Updated on 2025-02-11
1200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how continuing aspirin treatment around the time of surgery affects patients who have previously had coronary stents and are now scheduled for abdominal surgery. Since about 20% of patients with coronary stents undergo non-heart surgeries within three years, it's important to evaluate aspirin's role in preventing heart-related problems during this period. The study is conducted to fill the current lack of clear evidence about aspirin use in these cases. Participants in this trial will be randomly assigned to one of two groups. One group will continue taking aspirin during the perioperative period, while the other will stop aspirin 5 to 7 days before surgery. Both groups will be monitored closely during and after surgery to assess the effects of aspirin continuation versus interruption. During the study, participants will be observed for 30 days after surgery. Researchers will monitor outcomes such as death, heart attacks, strokes, bleeding events, and other cardiovascular complications. Various bleeding classifications and myocardial injury definitions will be used to evaluate safety and clinical outcomes. This comprehensive monitoring aims to provide clear data on risks and benefits related to aspirin use in this surgical context.
CONDITIONS
Brief Title
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a history of coronary stenting and scheduled for abdominal surgery
- Patients on a single antiplatelet agent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 7 days before surgery
Participants prepare for surgery and their aspirin use is managed according to their assigned group.
1 visit (in-person) before surgery
Duration - Up to 30 days after surgery
Participants undergo abdominal surgery while continuing or interrupting aspirin therapy as assigned.
1 visit at surgery and weekly visits for up to 4 weeks post-surgery
Duration - Up to 30 days after surgery
Participants are monitored for cardiovascular events and bleeding complications after surgery.
Approximately 4 post-operative visits
Trial Site Locations
Total: 1 location
1
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
Research Team
H
Hiroki Shiomi, MD, PhD
E
Erika Yamamoto, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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