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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209909
• Other study ID #: OPCAB_ASA_PLT activation
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: April 20, 2016
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• aspirin continuation
Patients are randomized to continue aspirin before OPCAB surgery.
• aspirin discontinuation
Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes