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CompletedNCT02209909Updated Apr 21, 2016

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

An interventional study of aspirin continuation and aspirin discontinuation in Coronary Artery Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-21.

Sponsored by Seoul National University Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • preoperative aspirin use
  • platelet activation
  • off pump coronary artery bypass
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 48 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    aspirin continuation

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

    Drug: aspirin continuation

  • Experimental
    aspirin discontinuation

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

    Drug: aspirin discontinuation

Interventions

  • Drugaspirin continuation

    Patients are randomized to continue aspirin before OPCAB surgery.

    Also known as: Low-dose aspirin (< 100mg/day)

  • Drugaspirin discontinuation

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

06

What researchers measure

Primary outcomes

  1. change from baseline in platelet p-selectin at 48 hours after operation

    Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.

    Time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Secondary outcomes

  1. change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation

    prothrombin time (international normalized ratio), activated partial thromboplastin time, fibrinogen

    Time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Other outcomes

  1. change from baseline in platelet aggregation at the time of end of operation, 24 hour after operation, and 48hr after operation

    prediction for stratification of bleeding risk due to antiplatelet agent using multiplate

    Time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02209909
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
Aug 6, 2014
Start date
Jul 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Apr 21, 2016

Study contacts

Yunseok Jeon, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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