NCT00911300

Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm

An International, Multicentre, Randomised, Open, Controlled, Two-parallel Group, Phase II Pilot Study to Evaluate the Efficacy and Safety of ARIXTRA™ for Anticoagulation of Patients With Atrial Fibrillation Undergoing Electric Cardioversion Following Transesophageal Echocardiography

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).

Conditions

• Fibrillation, Atrial

Interventions

Type	Name	Description
DRUG	fondaparinux	Comparison of different drugs
DRUG	unfractionated heparin	Comparison of different drugs
DRUG	Vitamin-K-Antagonist	Comparison of different drugs

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-06-01
• Last updated: 2012-10-01
• Results posted: 2012-09-05

Locations

34 sites across 2 countries: France, Germany