Clinical trial NCT00911300: Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrillation, Atrial
Keywords: Cardioversion, Electric
Pathological Conditions, Sings and Symptoms
Cardiovascular Diseases
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac
Pathologic Processes
Anticoagulants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: 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
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants
Secondary outcomes:
measure: Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
measure: Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
measure: Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
measure: Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
measure: Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
measure: Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm
timeFrame: Day 1 until Day 3
measure: 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
timeFrame: At second TEE (at Day 28+/-4)
measure: Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)
measure: Number of Participants Who Were Re-hospitalized
timeFrame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Other outcomes:
Locations:
city: Albi
country: France
facility: GSK Investigational Site
city: Antony cedex
country: France
facility: GSK Investigational Site
city: Brest Cedex
country: France
facility: GSK Investigational Site
city: Créteil
country: France
facility: GSK Investigational Site
city: Evecquemont
country: France
facility: GSK Investigational Site
city: Montpellier Cedex 5
country: France
facility: GSK Investigational Site
city: Paris cedex 12
country: France
facility: GSK Investigational Site
city: Paris cedex 13
country: France
facility: GSK Investigational Site
city: Pau
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Poitiers cedex
country: France
facility: GSK Investigational Site
city: Rennes Cedex 9
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 09
country: France
facility: GSK Investigational Site
city: Toulouse cedex 3
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bad Toelz
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Simbach a. Inn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hagenow
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Bielefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg-Huckingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Unna
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: