Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
Condition: Fibrillation, Atrial
MeSH terms: Atrial Fibrillation
Intervention: fondaparinux; unfractionated heparin; Vitamin-K-Antagonist
Intervention description: Comparison of different drugs; Comparison of different drugs; Comparison of different drugs
Intervention MeSH terms: Vitamin K; Heparin; Calcium heparin; PENTA; Fondaparinux
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardioversion, Electric; Pathological Conditions, Sings and Symptoms; Cardiovascular Diseases; Heart Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Pathologic Processes; Anticoagulants

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).
    

Eligibility criteria:

        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