Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI) has dramatically decreased the rate of early stent thrombosis. Further the CURE trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (ACS) . However clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. Another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors.
In addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk.
The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. This biological property was translated in the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the risk thrombotique. The ticagrelor is thus recommended in first intention in this indication. There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Marseille, France, 13354
- Assistance Publique Hôpitaux de Marseille
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.
Exclusion criteria:
- New York Heart Association functional class III or IV
- Cardiac arrest
- Contra-indications to antiplatelet therapy
- Platelet count <100 G/l
- History of bleeding diathesis
- Concurrent severe illness with expected survival of < 1 year month
- Pregnant of childbearing woman
- Inability to provide an informed consent
- Contra indication to ticagrelor.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Acute coronary syndrome patient
Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity
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Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor
Délai: one year
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Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose is associated with the occurrence of BARC bleedings ≥ 2 at one year post-PCI.
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one year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Relationship between VASP index and MACE
Délai: 1 month
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the rate of major cardiovascular events ( MACE )
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1 month
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Relationship between VASP index and MACE
Délai: 1 year
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1 year
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|
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Relationship between VASP index and BARC
Délai: 1month
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BARC: bleeding academic research complications
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1month
|
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Compliance to ticagrelor
Délai: 1 year
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1 year
|
|
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Evaluate Adenosine deaminase
Délai: 1 year
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1 year
|
|
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evaluate DDP IV activity
Délai: 1 year
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1 year
|
|
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Evaluate microparticules number and activity under ticagrelor
Délai: 1 year
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1 year
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Laurent BONELLO, MD, Assistance Publique Hôpitaux de Marseille
Publications et liens utiles
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 (Réel)
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
- 2014-A01913-44
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