Öffentliches Studienregister des CCC-München

Studie APPROACH-ACS-AF (CV185-398Wakili)

Studie Studiendesign Status Ein-/Auschlusskriterien Therapie Teilnehmer Dokumente Berechtigungen Tumorboards

Studie
World
Studienakronym
:
APPROACH-ACS-AF (CV185-398Wakili)
World
Vollständiger Titel
:

APixaban Versus PhenpRocoumon: Oral AntiCoagulation Plus Antiplatelet tHerapy in Patients With Acute Coronary Syndrome and Atrial Fibrillation

World
Beschreibung
:

Patients with atrial fibrillation (AF) presenting an acute coronary syndrome (ACS) and undergoing PCI require a triple therapy with a combination of oral anticoagulation (OAC) and dual anti-platelet therapy. Current guidelines recommend a regimen consisting of aspirin, clopidogrel and an oral anticoagulant. Although effective in preventing recurrent ischemia, triple therapy confers an elevated bleeding risk, which also has a major impact on the patients' prognosis and survival. Data from one randomized trial suggest that omitting aspirin in patients with indication for triple therapy may reduce the risk of bleeding without an increase of the rate of ischemic events. In addition, the recently introduced non-vitamin-K oral anticoagulants (NOACs) show less bleeding events as compared to vitamin-K antagonist in AF patients. In this trial it is postulated that a dual therapy consisting of the factor-Xa inhibitor apixaban and clopidogrel is associated with significant lower bleeding rates as compared to traditional triple therapy with aspirin, clopidogrel and a vitamin K antagonist (VKA). To test this hypothesis, patients with atrial fibrillation, who underwent PCI in the setting of an ACS will be randomized to either a dual therapy (apixaban+clopidogrel) or a triple therapy (aspirin+clopiodgrel+VKA). The patients will be followed-up for 6 months after randomization.

World
EudraCT-Nr.
:
World
NCT-Nr.
:
World
Zuständige Einrichtung
:
Med. I Lmu
Krankheitsentitäten
Klassifikation Code Beschreibung
Studiendesign
World
Verblindungstyp
:
Offen
World
Studienphase
:
IV
Status
World
Status
:
Rekrutierung aktiv
Voten
World
Ethikkommission - Votum
:
Positiv
Initiierung & Abschluß
World
Abschlussdatum (Plan / Ist)
:
Unbekannt / Unbekannt
Teilnehmer Die Studienleitung hat einer Freigabe der Kontaktdaten der Hauptprüfer bzw. Hauptansprechpartner nicht explizit zugestimmt.