- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01174862
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
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4031
- Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Aspirin responder
Normal aspirin responsiveness in ASPI test (Multiplate)
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Aspirin non-responder
Reduced aspirin responsiveness in ASPI test (Multiplate)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death and/or major cardiac or thromboembolic events
Time Frame: 12 months after cardiac surgery
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12 months after cardiac surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Bolliger, MD, Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 288/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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