Warfarin - How Good Are we at Maintaining Target Range ?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
NHS Tayside
Information provided by:
University of Dundee

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 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

Patients receiving Warfarin

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01081327

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

Responsible Party: Dr. Douglas Elder, University of Dundee 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

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