Aspirin Responsiveness and Outcome in Coronary Artery Bypass Graft (CABG) Surgery

Comparative Cohort Study on the Outcome of Patients With Normal and Reduced Acetylsalicylic Acid Responsiveness Undergoing Coronary Artery Bypass Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01174862

Enrollment

304

Registered

2010-08-04

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2015-03-10

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

Conditions

Antithrombotic Drugs [Platelet-aggregation Inhibitors] Causing Adverse Effects in Therapeutic Use, Coronary Artery Bypass Graft Triple Vessel, Myocardial Ischemia, Thrombosis

Keywords

aspirin, aspirin responsiveness, long-term outcome, CABG

Brief summary

In patients undergoing coronary artery bypass graft (CAGB) surgery, aspirin is commonly prescribed to prevent graft thrombosis and myocardial ischemia. However, there are still a significant number of grafts occluding in the postoperative period. This is partly attributed to reduced aspirin responsiveness, also called aspirin resistance. At the moment, no standardized definition or laboratory test is available to quantify aspirin resistance, and strong platelet reactivity in laboratory tests is not necessarily associated with increased thrombotic events. However, there is increasing evidence that reduced aspirin responsiveness in platelet function analyzers is associated with adverse long-term outcome and higher incidence of major adverse events in patients with stable coronary artery disease and in patients undergoing percutaneous coronary intervention. In patients undergoing coronary artery bypass graft surgery, the predictive value of a laboratory finding of reduced aspirin responsiveness remains unclear. Therefore, the aim of this study is to prospectively evaluate whether the pre- and/or postoperative laboratory finding of reduced aspirin responsiveness defined by MultiplateTM platelet function analyzer is associated with higher incidences of adverse outcome after 30 days and 12 months in patients undergoing CABG surgery.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patient undergoing elective CABG surgery * therapy with aspirin until at least 2 days before surgery * written informed consent

Exclusion criteria

* missing written consent * no therapy with aspirin or therapy stopped more than 2 days before surgery * therapy with clopidogrel more than 3 days before surgery * emergency surgery * surgery including more than CABG * inborn or acquired platelet disorders * therapy with Selective Serotonin reuptake inhibitors (SSRI) * severe hepatopathy (spontaneous Quick \<70%) * severe kidney disease (creatinine clearance \< 30 ml/min)

Design outcomes

Primary

Measure	Time frame
Death and/or major cardiac or thromboembolic events	12 months after cardiac surgery

Countries

Switzerland

Outcome results