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Completed

NCT Number: NCT02209909

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aspirin continuation

Drug

Patients are randomized to continue aspirin before OPCAB surgery.

Other names: Low-dose aspirin (< 100mg/day)

aspirin discontinuation

Drug

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

Primary outcomes

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

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

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

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

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

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

Other outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Apr 21, 2016

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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