Warfarin - How Good Are we at Maintaining Target Range ?

November 29, 2018 updated by: University of Dundee

Observational Record Linkage Study Investigating Incidence of Adverse Events in Patients Anti-coagulated for Lone Atrial Fibrillation.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Centre for Cardiovascular and Lung Biology, Univeristy of Dundee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients receiving Warfarin for lone atrial fibrillation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients receiving Warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding Complication
Time Frame: 10 years
Any bleeding event requiring hospitalisation and / or blood transfusion. Any death attributable to bleeding i.e. Intracerebral bleed.
10 years
Cardiovascular outcome
Time Frame: 10 years
Ischaemic event e.g. Cerebral infarction / Myocardial infarction / death attributed to ischaemic event
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

NHS Tayside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELD007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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