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Completed

NCT Number: NCT01174862

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Death and/or major cardiac or thromboembolic events

    Time frame: 12 months after cardiac surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 4, 2010
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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