Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspirin, Aspirin interruption.
- Who it may be relevant to
- Registry conditions: Antiplatelet Agents, Perioperative Care. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Drug Aspirin
perioperative aspirin continuation - Drug Aspirin interruption
Aspirin interruption 5-7 days before surgery
Primary outcome measures
- a composite of death or myocardial infarction [Time frame: 30 days]
Secondary outcome measures (12)
- Major bleeding (TIMI major/minor bleeding) [Time frame: 30 days]
- Death/Myocardial Infarction (4th UDMI Definition)/Stroke [Time frame: 30 days]
- Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS) [Time frame: 30 days]
- Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS) [Time frame: 30 days]
- Death/Myocardial Infarction (ARC-2 Definition)/Stroke [Time frame: 30 days]
- Death [Time frame: 30 days]
- Cardiovascular Death [Time frame: 30 days]
- Myocardial Infarction (4th UDMI Definition) [Time frame: 30 days]
- Myocardial Infarction (ARC-2 Definition) [Time frame: 30 days]
- Myocardial Infarction (SCAI Definition) [Time frame: 30 days]
- Myocardial Infarction (modified POISE-2 Definition) [Time frame: 30 days]
- Myocardial Injury (MINS) [Time frame: 30 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Kyoto University Hospital — Kyoto
Identifiers
NCT: NCT06723145 · Y0211 · 24ek0210198h0001