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Warfarin - How Good Are we at Maintaining Target Range ?

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ClinicalTrials.gov Identifier: NCT01081327
Recruitment Status : Unknown
Verified March 2010 by University of Dundee.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : June 25, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Patients with atrial fibrillation are often anticoagulated with Warfarin. Warfarin has a narrow therapeutic window requiring frequent monitoring. This study aims to investigate the incidence of adverse events in the "real world" for patients receiving Warfarin for lone atrial fibrillation.

Condition or disease
Atrial Fibrillation

Study Design

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Observational Record Linkage Study Investigating Incidence of Adverse Events in Patients Anti-coagulated for Lone Atrial Fibrillation.
Study Start Date : March 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients receiving Warfarin


Outcome Measures

Primary Outcome Measures :
  1. Bleeding Complication [ Time Frame: 10 years ]
    Any bleeding event requiring hospitalisation and / or blood transfusion. Any death attributable to bleeding i.e. Intracerebral bleed.

  2. Cardiovascular outcome [ Time Frame: 10 years ]
    Ischaemic event e.g. Cerebral infarction / Myocardial infarction / death attributed to ischaemic event


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients receiving Warfarin for lone atrial fibrillation
Criteria

Inclusion Criteria:

  • Prescription for Warfarin
  • Atrial Fibrillation

Exclusion Criteria:

  • Other conditions associated with increased risk of embolisation e.g. rheumatic valve disease, atrial mixoma.
  • Conditions with increased risk of bleeding.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081327


Locations
United Kingdom
Centre for Cardiovascular and Lung Biology, Univeristy of Dundee
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
NHS Tayside
More Information

Responsible Party: Dr. Douglas Elder, University of Dundee
ClinicalTrials.gov Identifier: NCT01081327     History of Changes
Other Study ID Numbers: ELD007
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: March 2010

Keywords provided by University of Dundee:
Atrial Fibrillation
Warfarin
Safety

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants