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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: aspirin continuation; Drug: aspirin discontinuation

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: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: platelet activation; preoperative aspirin use; off pump coronary artery bypass
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: OPCAB_ASA_PLT activation