Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery

NCT ID: NCT02209909

Last Updated: 2016-04-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-09-30

Brief Summary

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Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.

Detailed Description

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Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery.

Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In this study, we will compare platelet-activated markers and conventional coagulation tests.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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aspirin continuation

Intervention : Low-dose aspirin (\< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.

Group Type EXPERIMENTAL

aspirin continuation

Intervention Type DRUG

Patients are randomized to continue aspirin before OPCAB surgery.

aspirin discontinuation

Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.

Group Type EXPERIMENTAL

aspirin discontinuation

Intervention Type DRUG

Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.

Interventions

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aspirin continuation

Patients are randomized to continue aspirin before OPCAB surgery.

Intervention Type DRUG

aspirin discontinuation

Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.

Intervention Type DRUG

Other Intervention Names

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Low-dose aspirin (< 100mg/day)

Eligibility Criteria

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Inclusion Criteria

* age : 20-80
* elective OPCAB
* informed consent

Exclusion Criteria

* coagulation disorder
* emergency operation, re-operation
* co-existing valvular disease
* less than 6 months after cerebral vascular accident
* heparin induced thrombocytopenia
* heparin resistance
* menstrual phase
* preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application
* less than 12 months after myocardiac infarction
* less than 10 days after unstable angina
* less than 30 days after percutaneous coronary intervention
* less than 6 wks after bare metal stent insertion
* less than 12 months after drug eluting stent insertion
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yunseok Jeon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OPCAB_ASA_PLT activation

Identifier Type: -

Identifier Source: org_study_id

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