Conditions: Atrial Fibrillation
Keywords: Nonvalvular atrial fibrillation (NVAF) anti-coagulant warfarin edoxaban electrical cardioversion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2199
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

Detailed description:
The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples and urine samples.

The study is expected to show that edoxaban will provide comparable incidence rates to warfarin plus enoxaparin, the current standard treatment for both efficacy and bleeding.

Arms:
arm 1: Edoxaban oral tablet, 60 mg-once daily (QD), reduced to 30 mg based on protocol-defined parameters, for up to 49 days arm 2: Participants naïve to anticoagulation, taking anticoagulants other than a Vitamin K antagonist (VKA) or taking a VKA but with a prothrombin time (PT) international normalized ratio (INR) of less than 2.0 receive enoxaparin until they reach a PT INR of at least 2.0, before taking warfarin.

All participants in this arm receive warfarin oral tablet QD at their doctor's prescribed dose, for up to 49 days.

Interventions: intervention 1: Edoxaban intervention 2: Warfarin intervention 3: Enoxaparin
Intervention descriptions: intervention 1: Edoxaban 30 mg tablets for oral administration intervention 2: Warfarin tablet, 1.0 or 2.5 mg, for oral administration intervention 3: Enoxaparin per label, at prescribed dose until PT INR at least 2.0

Protocol document: