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

NCT01174862 | Completed

• 1 other identifier: 288/09
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

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

Keywords

aspirin; aspirin responsiveness; long-term outcome; CABG

Outcome Measures

Primary Outcomes (1)

• Death and/or major cardiac or thromboembolic events

  12 months after cardiac surgery

Study Arms (2)

Aspirin responder

Normal aspirin responsiveness in ASPI test (Multiplate)

Aspirin non-responder

Reduced aspirin responsiveness in ASPI test (Multiplate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective CABG surgery (on-pump and off pump surgery)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Myocardial Ischemia; Thrombosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis

Study Officials

• Daniel Bolliger, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Daniel Bolliger

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CH (1)