NCT01081327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 3, 2018

Status Verified

March 1, 2010

Enrollment Period

6 years

First QC Date

March 4, 2010

Last Update Submit

November 29, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationWarfarinSafety

Outcome Measures

Primary Outcomes (2)

  • Bleeding Complication

    Any bleeding event requiring hospitalisation and / or blood transfusion. Any death attributable to bleeding i.e. Intracerebral bleed.

    10 years

  • Cardiovascular outcome

    Ischaemic event e.g. Cerebral infarction / Myocardial infarction / death attributed to ischaemic event

    10 years

Study Arms (1)

Patients receiving Warfarin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving Warfarin for lone atrial fibrillation

You may qualify if:

  • Prescription for Warfarin
  • Atrial Fibrillation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Cardiovascular and Lung Biology, Univeristy of Dundee

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 3, 2018

Record last verified: 2010-03

Locations

GB(1)