At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 349 enrolled
Drug / intervention
fondaparinux +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating fondaparinux, unfractionated heparin, and 1 other intervention for Fibrillation, Atrial. Completed, enrolled 349 participants across 34 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrillation, Atrial
CountriesFrance, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartAug 2009
Primary CompletionSep 2011
TodayJul 2026
First PostedJun 1, 2009
Enrollment StartAug 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.1 years ago
Interventions
fondaparinuxdrug
Comparison of different drugs
unfractionated heparindrug
Comparison of different drugs
Vitamin-K-Antagonistdrug
Comparison of different drugs