Warfarin - How Good Are we at Maintaining Target Range ?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Dundee.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NHS Tayside
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01081327
First received: March 4, 2010
Last updated: June 24, 2010
Last verified: March 2010
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Dundee:

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

  • Cardiovascular outcome [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Ischaemic event e.g. Cerebral infarction / Myocardial infarction / death attributed to ischaemic event


Estimated Enrollment: 5000
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients receiving Warfarin

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Douglas Elder, University of Dundee
ClinicalTrials.gov Identifier: NCT01081327     History of Changes
Other Study ID Numbers: ELD007
Study First Received: March 4, 2010
Last Updated: June 24, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom : University of Dundee

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014