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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: aspirin continuation Drug: aspirin discontinuation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Official Title: Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
Study Start Date : July 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: aspirin continuation
Intervention : Low-dose aspirin (< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.
Drug: aspirin continuation
Patients are randomized to continue aspirin before OPCAB surgery.
Other Name: Low-dose aspirin (< 100mg/day)

Experimental: aspirin discontinuation
Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.
Drug: aspirin discontinuation
Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209909


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Yunseok Jeon, MD, PhD Seoul National University Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02209909     History of Changes
Other Study ID Numbers: OPCAB_ASA_PLT activation
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: August 2014

Keywords provided by Seoul National University Hospital:
preoperative aspirin use
platelet activation
off pump coronary artery bypass

Additional relevant MeSH terms:
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Aspirin
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics