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

NCT00911300 | Completed Phase 2 Results

• 1 other identifier: 111418
• Study Type: interventional
• Target: 349
• Locations: 2 countries
• Sites: 34

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).

Conditions

Fibrillation, Atrial

Keywords

Cardioversion, Electric; Pathological Conditions, Sings and Symptoms; Cardiovascular Diseases; Heart Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Pathologic Processes; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• 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

  Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.

  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 (9)

• Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event

  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)

• Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism

  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)

• Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause

  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)

• Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event

  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)

• Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event

  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)

Study Arms (2)

Arm 1: fondaparinux

ACTIVE COMPARATOR

Drug: fondaparinux

Arm 2: unfractionated heparin + Vitamin-K-Antagonist

ACTIVE COMPARATOR

Drug: unfractionated heparin; Drug: Vitamin-K-Antagonist

Interventions

fondaparinux DRUG

Comparison of different drugs

Arm 1: fondaparinux

unfractionated heparin DRUG

Comparison of different drugs

Arm 2: unfractionated heparin + Vitamin-K-Antagonist

Vitamin-K-Antagonist DRUG

Comparison of different drugs

Arm 2: unfractionated heparin + Vitamin-K-Antagonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (34)

GSK Investigational Site

Albi, 81000, France

Location

GSK Investigational Site

Antony, 92166, France

Location

GSK Investigational Site

Brest, 29609, France

Location

GSK Investigational Site

Créteil, 94000, France

Location

GSK Investigational Site

Évecquemont, 78740, France

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Paris, 75571, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Pau, 64046, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Poitiers, 86021, France

Location

GSK Investigational Site

Rennes, 35033, France

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Toulouse, 31076, France

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Aschaffenburg, Bavaria, 63739, Germany

Location

GSK Investigational Site

Bad Tölz, Bavaria, 83646, Germany

Location

GSK Investigational Site

Simbach A. Inn, Bavaria, 84359, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14467, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60488, Germany

Location

GSK Investigational Site

Kassel, Hesse, 34121, Germany

Location

GSK Investigational Site

Kassel, Hesse, 34125, Germany

Location

GSK Investigational Site

Hagenow, Mecklenburg-Vorpommern, 19230, Germany

Location

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, 33604, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53115, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Duisburg-Huckingen, North Rhine-Westphalia, 47259, Germany

Location

GSK Investigational Site

Unna, North Rhine-Westphalia, 59423, Germany

Location

GSK Investigational Site

Wesel, North Rhine-Westphalia, 46483, Germany

Location

GSK Investigational Site

Pirna, Saxony, 01796, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10249, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10405, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Pathologic Processes

Interventions

Fondaparinux; Heparin; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates; Glycosaminoglycans

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 1, 2012
• Results First Posted: September 5, 2012

Record last verified: 2012-09

Locations

DE (20); FR (14)