Warfarin - How Good Are we at Maintaining Target Range ?

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01081327

Enrollment

5000

Registered

2010-03-05

Start date

2010-03-31

Completion date

2016-03-01

Last updated

2018-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation, Warfarin, Safety

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results