Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
OPERATION
2 other identifiers
interventional
1,200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2024
CompletedFirst Posted
Study publicly available on registry
December 9, 2024
CompletedStudy Start
First participant enrolled
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 11, 2025
February 1, 2025
2.1 years
December 4, 2024
February 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
a composite of death or myocardial infarction
the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)
30 days
Secondary Outcomes (24)
Major bleeding (TIMI major/minor bleeding)
30 days
Death/Myocardial Infarction (4th UDMI Definition)/Stroke
30 days
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
30 days
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
30 days
Death/Myocardial Infarction (ARC-2 Definition)/Stroke
30 days
- +19 more secondary outcomes
Study Arms (2)
Aspirin Continuation
EXPERIMENTALperioperative aspirin continuation
Interruption of Antiplatelet Therapy
ACTIVE COMPARATORInterruption of aspirin 5-7 days before surgery
Interventions
Aspirin interruption 5-7 days before surgery
Eligibility Criteria
You may qualify if:
- Patients with a history of coronary stenting and scheduled for abdominal surgery
- Patients on a single antiplatelet agent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyoto Universitylead
Study Sites (1)
Kyoto University Hospital
Kyoto, 606-8507, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroki Shiomi, MD, PhD
Kyoto University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hiroki Shiomi MD, PhD
Study Record Dates
First Submitted
December 4, 2024
First Posted
December 9, 2024
Study Start
January 20, 2025
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share