It is hypothesised that a dual therapy strategy by oral anticoagulation with the new Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding bleeding events in patients with atrial fibrillation undergoing percutaneous coronary intervention in the setting of an acute coronary syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
403
Combination of Apixaban 5mg/dl (or in reduced dosing of 2.5 mg/d depending on age, renal function and body weight) in combination with Clopidogrel 75 mg/d for 6 months.
HAS-BLED-Score \<3: Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 6 months. HAS-BLED-Score ≥ 3: Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 1 month followed by Phrenprocoumon (INR 2.0-3.0) and Clopidogrel (75mg/d) for 5 months.
Munich University Hospital
Munich, Bavaria, Germany
Universitätsklinikum der RWTH Aachen
Aachen, Germany
Charité, Campus Benjamin Franklin
Berlin, Germany
The combined endpoint of moderate or major bleeding complications during the initial hospitalization and follow up (Bleeding Academic Research Consortium (BARC) type ≥ 2 bleeding)
Time frame: up to 6 months after randomization
Combined event of death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism and all the individual components of the composite secondary endpoint
Time frame: up to 6 months after randomization
Bleeding complications (Major bleeding: BARC > 3b bleeding)
Time frame: up to 6 months after randomization
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Charité, Campus Virchow-Klinikum
Berlin, Germany
Klinikum Coburg
Coburg, Germany
Westdeutsches Herzzentrum am Universitätsklinikum
Essen, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
UKHS Campus Kiel
Kiel, Germany
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