Phase 2
N=349
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
Fibrillation, Atrial
Bottom Line
View on ClinicalTrials.gov: NCT00911300 ↗Enrolled (actual)
349
Serious AEs
16.3%
Results posted
Sep 2012
Primary outcome: Primary: Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days — 3; 2 participants — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fondaparinux (Drug); unfractionated heparin (Drug); Vitamin-K-Antagonist (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days |
3; 2 | 1.000 |
| SECONDARY Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event |
0; 1; 0; 0; 1; 1 | — |
| SECONDARY Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause |
1; 0; 0; 0; 3; 0 | — |
| SECONDARY Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event |
3; 1; 0; 0; 4; 1 | — |
| SECONDARY Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event |
3; 4; 0; 0; 3; 5 | — |
| SECONDARY Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm |
137; 133 | — |
| SECONDARY Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE |
3; 7 | — |
| SECONDARY Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm |
109; 115; 5; 4; 105; 106 | — |
| SECONDARY Number of Participants Who Were Re-hospitalized |
14; 7; 18; 11 | — |
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
Data sourced from ClinicalTrials.gov (NCT00911300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.