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

NCT ID: NCT01174862

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Aspirin responder

Normal aspirin responsiveness in ASPI test (Multiplate)

No interventions assigned to this group

Aspirin non-responder

Reduced aspirin responsiveness in ASPI test (Multiplate)

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Daniel Bolliger

PD Dr. med. Daniel Bolliger

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Bolliger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

288/09

Identifier Type: -

Identifier Source: org_study_id