- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Basel-Stadt
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Basel, Basel-Stadt, Schweiz, 4031
- Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Death and/or major cardiac or thromboembolic events
Zeitfenster: 12 months after cardiac surgery
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12 months after cardiac surgery
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Daniel Bolliger, MD, Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 288/09
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