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

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ClinicalTrials.gov Identifier: NCT02209909
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 6, 2014
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02209909 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 5, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
Official Title  ICMJE Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: aspirin continuation
    Patients are randomized to continue aspirin before OPCAB surgery.
    Other Name: Low-dose aspirin (< 100mg/day)
  • Drug: aspirin discontinuation
    Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.
Study Arms  ICMJE
  • Experimental: aspirin continuation
    Intervention : Low-dose aspirin (< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.
    Intervention: Drug: aspirin continuation
  • Experimental: aspirin discontinuation
    Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.
    Intervention: Drug: aspirin discontinuation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02209909
Other Study ID Numbers  ICMJE OPCAB_ASA_PLT activation
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yunseok Jeon, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP