- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00139815
Michelangelo - Oasis 5
An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Study Objectives
PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.
SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.
- To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
- To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
- To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180
Study Drug: Patients will be randomized to receive either:
- Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
- Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection
Duration of Therapy:
- Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
- Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
- Patients should receive an ASA and all other standard medical therapies.
Substudy:
- A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (>48 hrs) coronary angiography and intervention.
Primary Outcome: The first occurence of any component of the following composite up to Day 9:
- Death
- Myocardial Infarction
- Refractory Ischemia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
- Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
- At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
- Written informed consent
Exclusion Criteria:
- Age < 21 years
- Any contraindication to low molecular weight heparin
- Hemorrhagic stroke within the last 12 months
- Indication for anticoagulation other than ACS.
- Pregnancy or women of childbearing potential who are not using an effective method of contraception
- Co-morbid condition with life expectancy less than 6 months
- Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Fondaparinux
|
fondaparinux 2.5 mg, s.c.
injection once daily x 8 days or Hospital Discharge if earlier and placebo-enoxaparin 1mg/kg s.c.
injection twice daily x 2-8 days or until clinically stable
|
Comparateur actif: Énoxaparine
|
enoxaparin 1mg/kg s.c.
injection twice daily x 2 to 8 days
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
death, myocardial infarction or refractory
Délai: up to and including Day 9
|
first occurrence of any component of death, myocardial infarction or
|
up to and including Day 9
|
major bleeding
Délai: Up to Day 9
|
incidence of adjudicated major bleeding
|
Up to Day 9
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Death, myocardial infarction or refractory
Délai: up to Day 9, Day 14, Day 30,
|
Incidence of the individual components of death, myocardial
|
up to Day 9, Day 14, Day 30,
|
major bleeding
Délai: up to and including Day 14, Day
|
incidence of adjudicated major bleeding
|
up to and including Day 14, Day
|
Any bleeding (major or minor)
Délai: up to and including Day 9, Day
|
Any bleeding (major or minor) as reported by the investigator as
|
up to and including Day 9, Day
|
Severe bleeding complications
Délai: up to and including Day 9, Day
|
Severe bleeding complications according to modified thrombolysis in
|
up to and including Day 9, Day
|
Death, myocardial infarction
Délai: up to Days 9, 14, 30, 90 and
|
composite of death, myocardial infarction
|
up to Days 9, 14, 30, 90 and
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators; Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006 Apr 6;354(14):1464-76. doi: 10.1056/NEJMoa055443. Epub 2006 Mar 14.
- Chow CK, Jolly S, Rao-Melacini P, Fox KA, Anand SS, Yusuf S. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes. Circulation. 2010 Feb 16;121(6):750-8. doi: 10.1161/CIRCULATIONAHA.109.891523. Epub 2010 Feb 1.
- Bassand JP, Afzal R, Eikelboom J, Wallentin L, Peters R, Budaj A, Fox KA, Joyner CD, Chrolavicius S, Granger CB, Mehta S, Yusuf S; OASIS 5 and OASIS 6 Investigators. Relationship between baseline haemoglobin and major bleeding complications in acute coronary syndromes. Eur Heart J. 2010 Jan;31(1):50-8. doi: 10.1093/eurheartj/ehp401. Epub 2009 Oct 12.
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
Mots clés
Termes MeSH pertinents supplémentaires
- Ischémie myocardique
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies vasculaires
- Embolie et thrombose
- Thromboembolie
- Syndrome coronarien aigu
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents fibrinolytiques
- Agents modulateurs de fibrine
- Inhibiteurs de protéase
- Inhibiteurs du facteur Xa
- Antithrombines
- Inhibiteurs de la sérine protéinase
- Anticoagulants
- Énoxaparine
- Fondaparinux
- PENTE
Autres numéros d'identification d'étude
- 103420
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Données/documents d'étude
-
Rapport d'étude clinique
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Ensemble de données de participant individuel
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulaire de rapport de cas annoté
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Plan d'analyse statistique
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Spécification du jeu de données
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocole d'étude
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulaire de consentement éclairé
Identifiant des informations: 103420Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .