Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)

Completed

Phase 3 Results

Trial Description

This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.
The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.
Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study

Patient Involvement

Patient must have ECG-documented atrial fibrillation and need long-term vitamin K antagonist therapy.

Outcomes

Type Measure Time Frame Safety Issue
Primary Find a replacement for vitamin K antagonists (especially warfarin) with agents that are comparably effective but less likely to cause bleeding and easier to use and manage.
Primary Composite of all strokes and non-CNS systemic embolism.
Secondary Separate components of the primary study outcome.

Sponsors