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

ConditionsAntiplatelet AgentsPerioperative Care
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorKyoto University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a history of coronary stenting and scheduled for abdominal surgery

Patients on a single antiplatelet agent

Disqualifiers

Patients on dual antiplatelet therapy (DAPT)

Patients on anticoagulation therapy

Patients with a history of stent thrombosis

Patients with CHADS2 score >= 5

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    perioperative aspirin continuation

  • Aspirin interruption

    Drug

    Aspirin interruption 5-7 days before surgery

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Aspirin ContinuationExperimental treatment 1 intervention
Group B: Interruption of Antiplatelet TherapyActive comparator 1 intervention

Trial outcomes

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)

Time frame
30 days

Secondary outcomes

1

Major bleeding (TIMI major/minor bleeding)

TIMI major/minor bleeding

Time frame
30 days
2

Death/Myocardial Infarction (4th UDMI Definition)/Stroke

a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke

Time frame
30 days
3

Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)

a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)

Time frame
30 days
4

Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)

a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS)

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyoto University

Lead sponsor

Source ClinicalTrials.gov
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