Kyoto University Hospital
Kyoto, 606-8507, Japan
Location status: Recruiting
Recruiting
NCT Number: NCT06723145
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Aspirin
Drugperioperative aspirin continuation
Other names: Aspirin (drug)
Aspirin interruption
DrugAspirin interruption 5-7 days before surgery
Other names: Aspirin interruption (drug)
Primary outcomes
-
a composite of death or myocardial infarction
Time frame: 30 days
the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)
Secondary outcomes
-
Major bleeding (TIMI major/minor bleeding)
Time frame: 30 days
TIMI major/minor bleeding
-
Death/Myocardial Infarction (4th UDMI Definition)/Stroke
Time frame: 30 days
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke
-
Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
Time frame: 30 days
a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
-
Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)
Time frame: 30 days
a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)
-
Death/Myocardial Infarction (ARC-2 Definition)/Stroke
Time frame: 30 days
a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke
-
Death
Time frame: 30 days
all-cause death
-
Cardiovascular Death
Time frame: 30 days
cardac and vascular death
-
Myocardial Infarction (4th UDMI Definition)
Time frame: 30 days
Myocardial Infarction defined by 4th UDMI Definition
-
Myocardial Infarction (ARC-2 Definition)
Time frame: 30 days
Myocardial Infarction defined by ARC-2 Definition
-
Myocardial Infarction (SCAI Definition)
Time frame: 30 days
Myocardial Infarction defined by SCAI Definition
-
Myocardial Infarction (modified POISE-2 Definition)
Time frame: 30 days
Myocardial Infarction defined by modified POISE-2 Definition
-
Myocardial Injury (MINS)
Time frame: 30 days
Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes.
-
Stent Thrombosis (ARC Definition)
Time frame: 30 days
Stent thrombosis defined by ARC definition
-
Stroke
Time frame: 30 days
Sudden neurological disorder that persists for at least 24 hours and is caused by blockage of cerebral blood flow due to bleeding or ischemia.
-
Cerebral Infarction
Time frame: 30 days
Sudden neurological disorder that persists for at least 24 hours and is caused by infarction.
-
Cerebral Hemorrhage
Time frame: 30 days
Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding.
-
Coronary Revascularization
Time frame: 30 days
PCI or CABG
-
Major Bleeding (BARC classification)
Time frame: 30 days
Major bleeding defined by BARC classification
-
Major Bleeding (modified POISE-2 classification)
Time frame: 30 days
Major bleeding defined by modified POISE-2 classification
-
Major Bleeding (GUSTO classification)
Time frame: 30 days
Major bleeding defined by GUSTO classification
-
Fatal Bleeding
Time frame: 30 days
Fatal bleeding within 30 days after abdominal surgery
-
Bleeding Volume During Non-Cardiac Surgery
Time frame: 30 days
bleeding volume during abdominal surgery
-
Transfusion
Time frame: 30 days
transfusion during and after surgery
-
Reoperation
Time frame: 30 days
any reoperation
Study contacts
Contact information is provided by the study sponsor or research team.
Erika Yamamoto, MD, PhD
CONTACT
Hiroki Shiomi, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Kyoto University
Other
Registry information
Acronym: OPERATION
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Dec 9, 2024
- Registry last updated
- Feb 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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