Aspirin Responsiveness and Outcome in Coronary Artery Bypass Graft (CABG) Surgery
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Purpose
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.
| Condition |
|---|
|
Coronary Artery Bypass Graft Triple Vessel Myocardial Ischemia Thrombosis Antithrombotic Drugs [Platelet-aggregation Inhibitors] Causing Adverse Effects in Therapeutic Use |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Comparative Cohort Study on the Outcome of Patients With Normal and Reduced Acetylsalicylic Acid Responsiveness Undergoing Coronary Artery Bypass Surgery |
| Estimated Enrollment: | 304 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Aspirin responder
Normal aspirin responsiveness in ASPI test (Multiplate)
|
|
Aspirin non-responder
Reduced aspirin responsiveness in ASPI test (Multiplate)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing elective CABG surgery (on-pump and off pump surgery)
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)
Contacts and Locations| Switzerland | |
| Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland | |
| Basel, Basel-Stadt, Switzerland, 4031 | |
| Principal Investigator: | Daniel Bolliger, MD | Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland |
More Information
No publications provided
| Responsible Party: | Daniel Bolliger, PD Dr. med. Daniel Bolliger, University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01174862 History of Changes |
| Other Study ID Numbers: | 288/09 |
| Study First Received: | August 2, 2010 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Basel, Switzerland:
|
aspirin aspirin responsiveness long-term outcome CABG |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Ischemia Thrombosis Heart Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes Embolism and Thrombosis Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013