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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Fibrillation, Atrial

Treatments

Drug: fondaparinux

Drug: unfractionated heparin

Drug: Vitamin-K-Antagonist

Study type

Interventional

Funder types

Industry

Identifiers

NCT00911300

111418

Details and patient eligibility

About

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).

Enrollment

349 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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