Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation

NCT ID: NCT06723145

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Antiplatelet Agents Perioperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin Continuation

perioperative aspirin continuation

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

perioperative aspirin continuation

Interruption of Antiplatelet Therapy

Interruption of aspirin 5-7 days before surgery

Group Type ACTIVE_COMPARATOR

Aspirin interruption

Intervention Type DRUG

Aspirin interruption 5-7 days before surgery

Interventions

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Aspirin

perioperative aspirin continuation

Intervention Type DRUG

Aspirin interruption

Aspirin interruption 5-7 days before surgery

Intervention Type DRUG

Other Intervention Names

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Aspirin (drug) Aspirin interruption (drug)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University

OTHER

Sponsor Role lead

Responsible Party

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Hiroki Shiomi

Hiroki Shiomi MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiroki Shiomi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University Hospital

Locations

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Kyoto University Hospital

Kyoto, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hiroki Shiomi, MD, PhD

Role: CONTACT

+81-75-751-4255

Erika Yamamoto, MD, PhD

Role: CONTACT

+81-75-751-4254

Facility Contacts

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Hiroki Shiomi, MD

Role: primary

+81-75-751-4255

Other Identifiers

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24ek0210198h0001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Y0211

Identifier Type: -

Identifier Source: org_study_id

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