MedDataX Logo

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

NCT ID: NCT00911300

Last Updated: 2012-10-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibrillation, Atrial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: fondaparinux

Group Type ACTIVE_COMPARATOR

fondaparinux

Intervention Type DRUG

Comparison of different drugs

Arm 2: unfractionated heparin + Vitamin-K-Antagonist

Group Type ACTIVE_COMPARATOR

unfractionated heparin

Intervention Type DRUG

Comparison of different drugs

Vitamin-K-Antagonist

Intervention Type DRUG

Comparison of different drugs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fondaparinux

Comparison of different drugs

Intervention Type DRUG

unfractionated heparin

Comparison of different drugs

Intervention Type DRUG

Vitamin-K-Antagonist

Comparison of different drugs

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Albi, , France

Site Status

GSK Investigational Site

Antony, , France

Site Status

GSK Investigational Site

Brest, , France

Site Status

GSK Investigational Site

Créteil, , France

Site Status

GSK Investigational Site

Évecquemont, , France

Site Status

GSK Investigational Site

Montpellier, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Pau, , France

Site Status

GSK Investigational Site

Pessac, , France

Site Status

GSK Investigational Site

Poitiers, , France

Site Status

GSK Investigational Site

Rennes, , France

Site Status

GSK Investigational Site

Toulouse, , France

Site Status

GSK Investigational Site

Toulouse, , France

Site Status

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Aschaffenburg, Bavaria, Germany

Site Status

GSK Investigational Site

Bad Tölz, Bavaria, Germany

Site Status

GSK Investigational Site

Simbach A. Inn, Bavaria, Germany

Site Status

GSK Investigational Site

Potsdam, Brandenburg, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Kassel, Hesse, Germany

Site Status

GSK Investigational Site

Kassel, Hesse, Germany

Site Status

GSK Investigational Site

Hagenow, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Duisburg-Huckingen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Unna, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Wesel, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Pirna, Saxony, Germany

Site Status

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

111418

Identifier Type: -

Identifier Source: org_study_id