Status:
COMPLETED
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
Lead Sponsor:
GlaxoSmithKline
Conditions:
Fibrillation, Atrial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Male or female patients aged at least 18 years with atrial fibrillation (AF) meeting at least one of the following criteria (a, b, c): a. Acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and AF on baseline ECG b. Newly discovered AF persisting for \>=7 days c. Recurrent AF persisting for \>=7 days
Exclusion
- No documented sinus rhythm on ECG for more than 1 year
- Acute neurological deficits (TIA, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
- Treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
- Treatment with oral NSAIDs or ASA at doses greater than 325 mg per day for more than 72 hours prior to randomisation
- Anticoagulant therapy required or likely to be required during the study period
- Treatment with ASA at a dose greater than 325 mg per day or oral NSAIDs (at any dose) required or likely to be required during the study period
- Treatment with two or more antiplatelet agents (e.g. clopidogrel and ASA) at any dose at the same time (i.e., within 24 hours)
- Known hypersensitivity to UFH, VKA, or Fondaparinux or one of these drugs' excipients
- Active, clinically significant bleeding or clinically significant bleeding within the past month
- Major surgery within the previous three months
- Uncontrolled arterial hypertension (persistent systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg)
- Bacterial endocarditis
- Calculated creatinine clearance \< 30 mL/min
- Body weight \< 50 kg
- Planned surgery or intervention within the next 65 days
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00911300
Start Date
August 1 2009
End Date
September 1 2011
Last Update
October 1 2012
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Albi, France, 81000
2
GSK Investigational Site
Antony, France, 92166
3
GSK Investigational Site
Brest, France, 29609
4
GSK Investigational Site
Créteil, France, 94000