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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209909
Enrollment
48
Registered
2014-08-06
Start date
2014-07-31
Completion date
2015-09-30
Last updated
2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

preoperative aspirin use, platelet activation, off pump coronary artery bypass

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.

Interventions

Patients are randomized to continue aspirin before OPCAB surgery.

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change from baseline in platelet p-selectin at 48 hours after operationafter induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operationPrimary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.

Secondary

MeasureTime frameDescription
change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operationafter induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operationprothrombin time (international normalized ratio), activated partial thromboplastin time, fibrinogen

Other

MeasureTime frameDescription
change from baseline in platelet aggregation at the time of end of operation, 24 hour after operation, and 48hr after operationafter induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operationprediction for stratification of bleeding risk due to antiplatelet agent using multiplate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026