- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Basel-Stadt
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Basel, Basel-Stadt, Suisse, 4031
- Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Death and/or major cardiac or thromboembolic events
Délai: 12 months after cardiac surgery
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12 months after cardiac surgery
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Daniel Bolliger, MD, Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 288/09
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